1 Rosenblum, Andrew et al., Opioids and the Treatment of Chronic Pain: Controversies, Current Status, and Future Directions, 16 Experimental & Clinical Psychopharmacology 405, 405 (2008)CrossRefGoogle ScholarPubMed (citation omitted).

2 See, e.g., Institute of Medicine, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research 1-4 (2011) (hereinafter IOM, Relieving Pain in America) (“The 2010 Patient Protection and Affordable Care Act required the Department of Health and Human Services (HHS) to enlist the Institute of Medicine (IOM) in examining pain as a public health problem.”). This is true over time, across clinical setting, patient age, and diagnosis. See generally id.

3 See, e.g., Rosenblum et al., supra note 1, at 406 (“During the 1990s, a major change occurred…. [t]he use of opioids for legitimate medical purposes has been accompanied by a substantial increase in the prevalence of nonmedical use of prescription opioids.”) (citation omitted).

4 Rosenblum et al., supra note 1, at 406. Opioids are only a small part of the overall treatment of pain and the public health problem of insufficient and inadequate treatment of pain is only somewhat related to the availability and appropriate use of prescription opioids. See, e.g., Goldberg, Daniel S. & McGee, Summer J., Pain As a Global Public Health Priority, 11 BMC Public Health, Oct. 2011, at 3CrossRefGoogle ScholarPubMed (“Thinking about global chronic pain as a public health priority implies immediately that the global focus on access to essential medicines like opioids is insufficient as a primary police strategy.”). In addition, evidence for the long term effectiveness for opioids in chronic pain is lacking. See, e.g., Chou, Roger et al., The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop, 162 Annals Internal Med. 276, 276 (2015)CrossRefGoogle ScholarPubMed (“[M]ost opioid trials do not extend beyond 6 weeks and are of limited relevance to long-term opioid use.”).

5 See Cheatle, Martin D. & Savage, Seddon R., Informed Consent in Opioid Therapy: A Potential Obligation and Opportunity, 44 J. Pain & Symptom Mgmt. 105, 106 (2012)CrossRefGoogle ScholarPubMed. It is a barrier but one of many and should not be conflated with the inadequate treatment of pain altogether. See, e.g., Goldberg, Daniel S., On the Erroneous Conflation of Opiophobia and the Undertreatment of Pain, 10 Am. J. Bioethics 20, 20 (2010)CrossRefGoogle ScholarPubMed.

6 Cheatle & Savage, supra note 5. This is a problem that has existed for probably as long as physicians had opioids at their disposal. See, e.g., Marks, Richard M. & Sachar, Edward J., Undertreatment of Medical Inpatients with Narcotic Analgesics, 78 Annals Internal Med. 173, 173 (1973)CrossRefGoogle ScholarPubMed (“Physicians who exaggerated the dangers of addiction were more likely to prescribe lower doses of drugs, even for patients with terminal malignancy…. causing much needless suffering ….”). Wesson and Smith described the tendency of the “legitimate” needs of some patients for access to be “overlooked” and overshadowed by the focus on curbing prescription drug abuse. See Wesson, Donald R. & Smith, David E., Prescription Drug Abuse: Patient, Physician, and Cultural Responsibilities, 152 W. J. Med. 613, 613 (1990)Google ScholarPubMed.

7 See Dickson, Barry D. et al., Use of Opioids to Treat Chronic, Noncancer Pain, 172 W. J. Med. 107, 109 (2000)CrossRefGoogle Scholar (“Reports [on the effect of opioid use on pain] encompassing more than 1000 patients have described favorable outcomes in selected samples of patients.”).

8 See, e.g., United States v. Purdue Frederick Co., 495 F.Supp.2d 569, 576 (W.D. Va. 2007) (accepting the plea deals between Purdue, three of its executives, and the United States). Purdue Pharmaceuticals and associated companies engaged in flagrant dissemination of patently untrue information about Oxycontin, ultimately resulting in over 600 million dollars in fines. Between 1995 and 2001, the company advanced that Oxycontin was “less addictive” and more abuse deterrent than immediate release versions of oxycodone. Id. at 571-72. These claims were both untrue and noted as such in the scientific evaluation of the drug during FDA approval. Emily Chasan, Pursue Frederick Pleads Guilty in OxyContin Case, Reuters (May 10, 2007, 2:27 PM), http://www.reuters.com/article/us-oxycontin-misbranding-idUSWBT00695020070510 [http://perma.cc/ARZ4-CCVH]; see also Griffin, O. Hayden III & Miller, Bryan Lee, OxyContin and a Regulation Deficiency of the Pharmaceutical Industry: Rethinking State-Corporate Crime, 19 Critical Criminology 213 (2010)CrossRefGoogle Scholar; Lexchin, Joel & Kohler, Jillian Clare, The Danger of Imperfect Regulation: OxyContin Use in the United States and Canada, 23 Int'l J. Risk & Safety Med., 233 (2011)CrossRefGoogle ScholarPubMed.

9 Cheatle & Savage, supra note 5 (“There is growing consensus that opioid treatment agreements … or contracts are an important component of clinical management of opioid therapy for pain….”) (citation omitted); see, e.g., de Leon-Casasola, Oscar A., Opioids for Chronic Pain: New Evidence, New Strategies, Safe Prescribing, 126 Am. J. Med. S3, S9 (2013)CrossRefGoogle Scholar (“Opioids are a viable treatment alternative in patients with pain ….”).

10 Dart, Richard C. et al., Trends in Opioid Analgesic Abuse and Mortality in the United States, 372 New Eng. J. Med. 241, 242 (2015).CrossRefGoogle ScholarPubMed

11 The Diagnostic and Statistical Manual, Fifth Edition (DSM-V) combines previous definitions of substance abuse and substance dependence into a substance use disorder spectrum ranging from mild to severe. Am. Psychiatric Ass'n Substance Related and Addictive Disorders 1-2 (2013) http://www.dsm5.org/Documents/Substance%20Use%20Disorder%20Fact%20Sheet.pdf [http://perma.cc/9UQA-XCL9].

12 See, e.g., Rigg, Khary K. & Murphy, John W., Understanding the Etiology of Prescription Opioid Abuse: Implications for Prevention and Treatment, 23 Qualitative Health Res. 963, 965 (2013)CrossRefGoogle ScholarPubMed (identifying themes of opioid misuse emerging after heroin or cocaine use as well as some who initially took opioids as prescribed but switched to abuse after experiencing euphoric effects); see also Ling, Walter et al., Prescription Opioid Abuse, Pain and Addiction: Clinical Issues and Implications, 30 Drug & Alcohol Rev. 300, 300 (2011)CrossRefGoogle ScholarPubMed (addressing the increasing public health problem of opioid misuse).

13 Dart et al., supra note 10; Harold Pollack, 100 Americans Due of drug Overdoses Each Day. How Do We Stop That?, Wash Post. (Feb. 7, 2014), https://www.washingtonpost.com/news/wonk/wp/2014/02/07/100-americans-die-of-drug-overdoses-each-day-how-do-we-stop-that/ [http://perma.cc/4QFR-P76B]. The majority of those involved polysubstance ingestion or Methadone. Pollack, supra note 13; see HHS, Substance Abuse & Mental Health Services Administration, Drug Abuse Warning Network, 2011: National Estimates of Drug Related Emergency Department Visits, HHS Publication No. (SMA) 13-4760, DAWN Series D-39 (2013) [hereinafter Drug Related Visits Study].

14 The attention was certainly more than the problem of suffering and pain garner. See, e.g., Peter Eisler, Seniors and Prescription Drugs: As Misuse Rises, So Does the Toll, USA Today (May 22, 2014), http://www.usatoday.com/story/news/nation/2014/05/20/seniors-addiction-prescription-drugs-painkillers/9277489/ [http://perma.cc/S8QU-T7MY] (arguing that the “medical community … is often quick to offer narcotic painkillers ….”); Aaron Glanz, Opiates Handed Out Like Candy to ‘Doped Up’ Veterans at Wisconsin VA, Reveal (Jan. 8, 2015) http://www.revealnews.org/article-legacy/opiates-handed-out-like-candy-to-doped-up-veterans-at-wisconsin-va/ [http://perma.cc/Q5PG-NUA9] (noting that veterans refer to the VA medical center in Wisconsin as “candy land”); Lynn Webster, NFL Players Reveal Nation's Poor Treatment of Chronic Pain, Chicago Sun Times (Aug. 26, 2014), http://espn.go.com/nfl/story/_/id/10958191/nfl-illegally-supplied-risky-painkilling-drugs-former-players-allege-suit [http://perma.cc/7ARU-D242] (arguing that more must be done to treat chronic pain); Graeme Wood, Doctors Without Moral Borders: What Makes This Drug Crisis Different From All Other Drug Crises?, The New Republic (Mar. 24, 2014) (“[M]odern medicine hasn't yet figured out a universally effective way to wean abusers off long-term addiction; some will be sliding up to a methadone-clinic window every morning for the rest of their lives. And their addictions will continue the way they began, just as the doctor ordered.”).

15 See Fed'n of State Med. Bds., Model Policy on the Use of Opioid Analgesics in the Treatment of Pain 3 (2013) [hereinafter FSMB, Model Policy on the Use of Opioids] (“inappropriate prescribing can contribute to adverse outcomes such as reduced function, opioid addiction, overdose, and death”) (citation omitted).

16 Blanco, Carlos et al., Probability and Predictors of Treatment-Seeking for Prescription Opioid Use Disorders: A National Study, 131 Drug & Alcohol Dependence, 143, 143 (2013)CrossRefGoogle ScholarPubMed. OUD does include those addicted to heroin as well but prescription opioid addictions are more common. Compton, Wilson M. et al., Prescription Opioid Abuse: Problems and Responses, 80 Preventive Med. 5, 5 (2015)CrossRefGoogle ScholarPubMed. It is worth noting that the overall rate of SUD has not increased over the last decade. See Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality, Treatment Episode Data Sets: 2000-2012. BHSIS Series S-72, HHS Publication No. (SMA) 14-4889 1 (2014).

17 Blanco et al., supra note 16, at 144 (estimating that the lifetime probability of seeking treatment for those with OUDs is 42%). This fact is even more shocking considering the recognition of SUD as a disease is more than a century old. See, e.g., W.H. Willcox, Norman Kerr Memorial Lecture on Drug Addiction, Brit.Med. J. 1013-16 (1923) (“The only treatment that gives a hopeful prospect of complete cure is one which recognizes that drug addiction is a disease, and as such requires the same careful attention to detail [as] any other disease ….”).

18 See generally Meyer, Roxanne et al., Prescription Opioid Abuse: A Literature Review of the Clinical and Economic Burden in the United States, 17 Population Health Mgmt. 372 (2014)CrossRefGoogle ScholarPubMed; Pasquale, Margaret K. et al., Cost Drivers of Prescription Opioid Abuse in Commercial and Medicare Populations, 14 Pain Practice E116 (2014)CrossRefGoogle ScholarPubMed.

19 See, e.g., Jane Friedmann, Board Penalizes Pharmacists, Star Tribune (Feb. 13, 2011) (detailing disciplinary action against pharmacists who diverted supplies of medication). Distributors, dispensers, and prescribers are all subject to diversion of legally manufactured prescription opioids through distribution and dispensing thefts, prescription fraud, and even valid prescriptions. See, e.g., Fischer, Benedikt et al., The Global Diversion of Pharmaceutical Drug: Non-Medical Use and Diversion of Psychotropic Prescription Drugs in North America: A Review of Sourcing Routes and Control Measures, 105 Addiction 2062 (2010)CrossRefGoogle ScholarPubMed (“[S]everal general population studies have found that a large proportion of non-medical users obtained PPDs informally from people they commonly know or relate to … and typically do so for free.”); Karen Blum, Case of Large-Scale Opioid Diversion Puts Hospitals on Alert, Pain Med. News (Sept. 2, 2014), http://painmedicinenews.com/Policy-Management/Article/09-14/Case-of-Large-Scale-Opioid-Diversion-Puts-Hospitals-on-Alert/28093/ses=ogst (reporting on arrest of former pharmacy director for Beth Israel Medical Center, who allegedly diverted nearly 200,000 oxycodone pills over five years for street distribution by using his access to secure systems); see also Mark Lowery, Top Ten States for Pharmacy Robberies, DrugTopics (Oct. 7, 2014) http://drugtopics.modernmedicine.com/drug-topics/content/tags/arizona/top-10-states-pharmacy-robberies.

20 See Jones, Christopher M. et al., Sources of Prescription Opioid Pain Reliever by Frequency of Past Year Non-Medical Use, 2008-2011, 174 J. Am. Med. Ass'n Internal Med. 802, 802-03 (May 2014)Google Scholar (“Most nonmedical users obtained opioid pain relievers from friends and relatives for free …; however, the source varied significantly by frequency of nonmedical use. Opioid pain relievers were obtained from a friend or a relative for free with decreasing frequency (from 61.9% to 26.4%) as the reported days of nonmedical use increased from a range of 1 to 29 to a range of 200 to 365. Opioid pain relievers were obtained from other sources, including prescriptions from physicians and purchases from a friend or a relative or from a drug dealer or a stranger, with greater frequency as the reported days of nonmedical use increased.”); see also Substance Abuse & Mental Health Services Administration, Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-48, HHS Publication No. (SMA) 14-4863 (2014) (“Rates averaged across 2012 and 2013 show that more than half of the nonmedical users of pain relievers, tranquilizers, stimulants, and sedatives aged 12 or older got the prescription drugs they most recently used ‘from a friend or relative for free.’ More than four in five of these nonmedical users who obtained prescription drugs from a friend or relative for free indicated that their friend or relative had obtained the drugs from one doctor.”).

21 See Lewis, Eleanor T. et al., What Do Patients Do with Unused Opioid Medications? 30 Clinical J. Pain 654, 654 (2014)CrossRefGoogle ScholarPubMed. The degree of left over and unsecured opioids in homes is a significant problem. Id. at 655, 660. Drug take back and safe storage programs are aimed at reducing this source. See, e.g., Disposal of Controlled Substances, 79 Fed. Reg. 53520, 53520 (Sept. 9, 2014) (The Rule “implements regulations that expand the entities to which ultimate users may transfer unused, unwanted, or expired pharmaceutical controlled substance ….”).

22 Christopher Jones et al., supra note 20, at 803 (“Among nonmedical users reporting 200 to 365 days of use, opioid pain relievers were most often obtained via prescription from physicians (27.3%).”).

23 In March 2015, the Secretary of Health and Human Services announced a new three-part initiative to address opioid use disorders. See HHS, Opioid Abuse in the U.S. and HHS Actions to Address Opioid-Drug Related Overdoses and Deaths, ASPE Issue brief, 1, 1 (2015), http://www.hhs.gov/news/press/2015pres/03/20150326a.html [http://perma.cc/9SSL-B99K]. Prescribing practices are the third part of the initiative. Id.

24 See supra notes 8-18 and accompanying text.

25 See Barnes, Michael C. & Sklaver, Stacey L., Active Verification and Vigilance: A Method to Avoid Civil and Criminal Liability when Prescribing Controlled Substances, 15 DePaul J. Health Care L. 93, 100 (2013)Google Scholar. This too, is a multifaceted problem, in part because physicians are so poorly trained in recognizing and appropriately treating or referring patient with SUDs alone much less those who also have complex comorbid conditions. See McLellan, A. Thomas et al., Can Substance Use Disorders be Managed Using the Chronic Care Model?: Review and Recommendations from a NIDA Consensus Group, 35 Pub. Health Rev. 1, 6-7 (2014)Google ScholarPubMed.

26 See, e.g., Barnes & Sklaver, supra note 25 (“Additionally, the [Controlled Substances Act] imposes a criminal duty on physicians ….”).

27 See, e.g., Cheatle & Savage, supra note 5 (“[M]any pain expert agree that opioids remain the most effective analgesics available.”).

28 See, e.g., Victoria Kim, L.A. Doctor, 4 Others Arrested in Prescription Drug ‘Pill Mill’ Case, L.A. Times, (Jan. 13, 2015), http://www.latimes.com/local/lanow/la-me-ln-prescription-drug-pill-mill-arrests-20150113-story.html [http://perma.cc/5392-5A8B] (discussing the arrest of physicians in connection with selling prescription drugs illegally); Press Release, New York Attorney General, A.G. Schneiderman Announces Guilty Plea of Manhattan Doctor For Selling Oxycodone Prescriptions to Drug Dealers (Mar. 1, 2013), http://www.ag.ny.gov/press-release/ag-schneiderman-announces-guilty-plea-manhattan-doctor-selling-oxycodone-prescriptions (describing a cash for prescriptions of oxycodone scheme which netted a Manhattan physician nearly $500,000 in cash over several years).

29 See Hoffmann, Diane E. & Tarzian, Anita J., Achieving the Right Balance in Oversight of Physician Opioid Prescribing for Pain: the Role of State Medical Boards, 31 J.L. Med. & Ethics 21, 35 (2003)CrossRefGoogle ScholarPubMed.

30 Wesson & Smith, supra note 6, at 614. The 4D model was adopted by the Amer. Medical Ass'n (AMA) in the 1980s following the 1980 White House Conference on Prescription Drug Abuse. Id.

31 Id. at 614 (describing the framework as intended to “stimulate educational alternatives for the dated or duped physicians” and as being “pragmatically useful” because several state boards of medicine did begin offering educational strategies and other “alternatives to discipline”).

32 See, e.g., id. at 616 (Wesson and Smith urged refinement of the model, especially the duped category in 1990).

33 See, e.g., Hoffmann & Tarzian, supra note 29 (board of medicine members struggle with the idea of being duped as a measure, one said “[i]t's the standard of care to take care of people's pain just like it's the standard of care not to be duped”); Anderson Spickard Jr. et al., Changes Made by Physicians Who Misprescribed, 88 J. Med. Licensure & Discipline 110, 110 (2002) (“Physicians cited for prescribing by a state medical board generally fall into two distinct groups: those who abuse (disabled) and/or sell drugs (dishonest), and physicians whose misprescribing results from a variety of other causes (dated, duped)”); Eric A. Voth, Prescribing Controlled Substances Reconsidered, 2 J. Global Drug Pol'y & Practice (2008) (discussing the meaning of “Dated,” Duped,” “Disabled,” and “Dishonesty”).

34 Johnson, Sandra H., Test Driving “Patient-Centered Health Law,” 45 Wake Forest L. Rev. 1475, 1479 (2010)Google Scholar (“[I]f laws stigmatize pain patients by intimidating doctors with threats of investigation, discipline, or criminal prosecution, these laws are not patient centered.”).

35 Sandra H. Johnson describes these as patient-centered health laws. Id. at 1475.

36 See Mumford, Michael D. et al., Integrity in Professional Settings: Individual and Situational Influences, in 34 Advances in Psychology 222–223 (Shohov, S., ed., 2005)Google Scholar. Integrity means making decisions that maximize the primary well-being of the patient, even in situations with various constituencies and conflicting needs. See id.

37 See, e.g., United States v. Ilayayev, 800 F.Supp.2d 417, 436 (E.D. N.Y. 2011) (explaining that physicians are in a “precarious position when considering prescribing opioid[s]”).

38 Wesson & Smith, supra note 6, at 615.

39 See, e.g., Wolfe, Sidney M., Misprescribing and Overprescribing of Drugs, 26 Public Citizen Health Letters 1, 4 (2010)Google Scholar (using the term “misprescribing” to refer to patients' adverse reactions).

40 Rich, Ben A. & Webster, Lynn R., A Review of Forensic Implications of Opioid Prescribing with Examples from Malpractice Cases Involving Opioid-Related Overdose, 12 Pain Med. S59, S59 (2011)CrossRefGoogle ScholarPubMed (citation omitted).

41 See, e.g., Khaliq, Amir A. et al., Disciplinary Action Against Physicians: Who Is Likely to Get Disciplined?, 118 Am. J. Med. 773 (2005)CrossRefGoogle ScholarPubMed (exploring the “spectrum of characteristics of physicians by the Oklahoma Board of Medical Licensure and Supervision since its inception in 1922); Kohatsu, Neal D. et al., Characteristics Associated with Physician Discipline: A Case-Control Study. 164 Archives Internal Med. 653 (2004)CrossRefGoogle ScholarPubMed (studying California Board of Medicine cases between 1998 and 2001).

42 See, e.g., Heumann, Milton et al., Prescribing Justice: The Law and Politics of Discipline for Physician Felony Offenders, 17 B.U. Pub. Interest L.J. 1 (2007)Google Scholar (studying discipline and felony convictions of physicians in New Jersey through 2006); Kohatsu et al., supra note 41; Morrison, James & Wickersham, Peter, Physicians Disciplined by a State Medical Board, 279 J. Am. Med. Ass'n 1889 (1998)CrossRefGoogle ScholarPubMed (studying discipline by the California medical board from 1995 to1997).

43 See, e.g., Arora, Kavita Shah et al., What Brings Physicians to Disciplinary Review? A Further Subcategorization, 5 Am. J. Bioethics Empirical Bioethics 53 (2014)CrossRefGoogle Scholar (acknowledging that studying data from the AMA eliminates most physicians because the majority of U.S. physicians are not members of the AMA).

44 See, e.g., Arora et al., supra note 43 (focusing on the AMA disciplinary process applicable to members only); Goldenbaum, Donald M. et al., Physicians Charged with Opioid Analgesic-Prescribing Offenses, 9 Forensic Pain Med. 737 (2008)CrossRefGoogle ScholarPubMed (studying criminal and administrative cases from 1998-2006); Jung, Paul et al., U.S. Physicians Disciplined for Criminal Activity, 16 Health Matrix 335 (2006)Google ScholarPubMed (studying data on state board discipline for criminal sanctions between 1990 and 1999). et al., Physicians Charged with Opioid Analgesic-Prescribing Offenses, 9 Forensic Pain Med.

45 See supra notes 41-44.

46 Kohatsu et al., supra note 41, at 655; Jung et al., supra note 44, at 343;

47 Goldenbaum et al., supra note 44, at 742; Khaliq et al., supra note 41, at 776; Kohatsu et al., supra note 41, at 655.

48 Kohatsu et al., supra note 41, at 655.

49 Khaliq et al., supra note 41, at 775; Kohatsu et al., supra note 41, at 655; Jung et al., supra note 44, at 341.

50 Goldenbaum et al., supra note 44, at 742.

51 James M. DuBois, et al., A Content Analysis of Reports on 100 Cases of Improper Prescribing of Controlled Substances, J. Drug Issues (2015) (forthcoming).

52 Rich & Webster, supra note 40.

53 See id. at S60-62 (physician errors included 1) starting “opioid-naïve patients” on excessive and dangerous doses of drugs, 2) inaccurately converting the doses from one opioid to another and resulting in too high of dose, and 3) directing too rapid an escalation in doses and 4) failing to screen for comorbidities while patient behaviors were self-medication, self-escalation of doses, and polysubstance abuse).

54 Id. at S61-62.

55 See generally id. (exploring the effects of physician error in the context of prescribing opioids).

56 For example, many states have seriously restricted physicians' ability to practice as pain specialists, created detailed practice standards for prescribing, or similar actions. See, e.g., Tenn. Code. Ann. § 63-1-301 (2010 & Supp. 2015) (including a definition for “[p]ain management clinic”); Fla. Stat. § 459.0137 (2007 & Supp. 2016) (detailing specific requirements for “[p]ain-management clinics”). The DEA has also invested significant resources into new tactical diversion squads charged with investigating doctors and pharmacies as potential sources of diversion. See Joseph T. Rannazzisi, Deputy Asst. Administrator, Drug Enforcement Agency, U.S. Dep't of Justice, Statement for the Record: Responding to the Prescription Drug Abuse Epidemic, U.S. Senate Caucus on International Narcotics Control (July 18, 2012), http://www.dea.gov/pr/speeches-testimony/2012-2009/responding-to-prescription-drug-abuse.PDF [http://perma.cc/C3RP-9LLK].

57 Lingard, Lorelei & Haber, Richard J., Teaching and Learning Communication in Medicine: A Rhetorical Approach, 74 Academic Med. 507, 507 (1999)CrossRefGoogle Scholar.

58 Wesson & Smith, supra note 6, at 614; see Longo, Lance P. et al., Addiction: Part II. Identification and Management of the Drug-Seeking Patient, 61 Am. Fam. Physician 2401, 2405 (2000)Google ScholarPubMed.

59 Smith, David E., Prescribing Practices and the Prescription Drug Epidemic: Physician Intervention Strategies, 44 J. Psychoactive Drugs 68, 70-72 (2012)CrossRefGoogle ScholarPubMed.

60 Id. at 70 (describing the adoption of the model by the DEA and state medical boards).

61 Id.

62 Longo et al., supra note 58.

63 Wesson & Smith, supra note 6, at 616.

64 Id. at 615.

65 Id. at 615-16. Two additional Ds were later suggested but never adopted: dismayed (careless because of “time constraints,” external pressures) and dysfunctional (unable to say no to anyone because of psychological or personality traits). Brown, Martha E. et al., Searching for Answers: Proper Prescribing of Controlled Prescription Drugs, 44 J. Psychoactive Drugs 79, 80-81 (2012)CrossRefGoogle ScholarPubMed. We focus on the AMA's 4D model and recommend changes because while these two additional categories provided some further explanations, but still are under-inclusive.

66 Ziegler, Stephen J., Pain, Patients, and Prosecution: Who is Deceiving Whom?, 8 Pain Med. 445, 446 (2007)CrossRefGoogle ScholarPubMed.

67 Longo et al., supra note 58.

68 Wesson & Smith, supra note 6, at 616 (“Drug abusers … may create the illusion … that they are seeking medical attention for a disease or illness for which the desired drug would be appropriate. Scams for medications can be quite sophisticated, innovative, and impossible to unravel in the time available for the physician-patient interaction.”).

69 Drummond, Karen L., “I Feel Like His Dealer”: Narratives Underlying a Case Discussion in a Palliative Medicine Rotation, 30 Literature & Med. 124, 134 (2012)CrossRefGoogle Scholar.

70 Id.

71 See, e.g., Jung, Beth & Reidenberg, Marcus M., Physicians Being Deceived, 8 Pain Med. 433, 433 (2007)CrossRefGoogle ScholarPubMed (“Our review of [DEA] … actions against physicians who prescribed opioids found that some of these actions were based on prescriptions given to undercover agents. In several high-profile prosecutions of physicians for prescribing opioids, prosecutors claimed that the doctors should have known the individuals were feigning pain solely to obtain the prescriptions.”) (citation omitted); Reidenberg, M. M. & Willis, O., Prosecution of Physicians for Prescribing Opioids to Patients, 81 Clinical Pharmacology & Therapeutics 903, 904 (2007)CrossRefGoogle ScholarPubMed (finding that in many of the cases they reviewed between 2004 and 2005, the focus was on the fact that undercover officers had “fooled” the physician); Hailey Branson-Potts, L.A. Times Blog (June 15, 2012, 6:11 PM), http://latimesblogs.latimes.com/lanow/2012/06/doctor-charged-with-murder-supplied-addict-with-hundreds-of-addictive-pills-each-week-former-patient.html [http://perma.cc/U5B2-6WB9] (“In two weeks of testimony, prosecution witnesses have said they exaggerated or lied to [the doctor] about suffering pain and walked away with their desired prescriptions after little or no examination.”).

72 Jung & Reidenberg, supra note 71.

73 Ziegler, supra note 66, at 445.

74 See, e.g., Hellman, Deborah, Prosecuting Doctors for Trusting Patients, 16 George Mason L. Rev. 701, 702 (2009)Google Scholar (arguing that physicians should trust their patients).

75 See Reidenberg & Willis, supra note 71, at S905 (identifying being deceived as one of three groups of physicians investigated for misprescribing); see generally Jung & Reidenberg, supra note 71 (describing many DEA actions focusing on deception of physicians).

76 Bartlett, Marian Stewart et al., Automatic Decoding of Facial Movements Reveals Deceptive Pain Expressions, 24 Current Biology 738, 738, 740 (2014)CrossRefGoogle ScholarPubMed (finding computer vision system was more accurate, at 85%, than humans).

77 Jung & Reidenberg, supra note 71, at 434. There are also well documented problems with disbelief of patient reports of pain, but this could be worsened in part by the language of duped. See id. at 435.

78 See, e.g., id. at 434-35 (reviewing the results of six studies on standardized patients and physician detection).

79 See Rich & Webster, supra note 40, at S64.

80 See Johnson, Sandra H., Regulating Physician Behavior: Taking Doctors' “Bad Law” Claims Seriously, 53 St. Louis U. L.J. 973, 988 (2009)Google Scholar [hereinafter Johnson, Regulating] (noting that physician decisions were historically accorded deference because of the paternalistic relationship between doctor and patient).

81 Jung & Reidenberg, supra note 71, at 436.

82 See Reidenberg & Willis, supra note 71, at 903. There is continuing evidence that patients in pain face discounting and sometime outright suspicion by physicians. The language of duped may underlie or exacerbate this problem. See, e.g., Jung & Reidenberg, supra note 71, at 436 (“When portions of the medical press describe cases of physicians accused of diverting controlled substances because they were deceived, suspicion of patients with chronic pain complaints increases.”).

83 Jung & Reidenberg, supra note 71, at 435.

84 See Kassin, Saul M. et al., Police Interviewing and Interrogation: A Self-Report Survey of Police Practices and Beliefs, 31 L. & Hum. Behav. 381, 393-94 (2007)CrossRefGoogle ScholarPubMed (finding survey participants estimated their lie detection abilities at 77% but reality is about 54%).

85 See, e.g., Vrij, Aldert et al., Pitfalls and Opportunities in Nonverbal and Verbal Lie Detection, 11 Psychological Science Pub. Int. 89 97-98 (2010)CrossRefGoogle ScholarPubMed. For example, as opposed to not making eye contact, liars will work to maintain eye contact while truth tellers scanning their memories may often shift their gazes. Id. at 96.

86 See Kassin et al., supra note 84 at 382-83; see also Vrij, Aldert & Granhag, Pär Anders, Eliciting Cues to Deception and Truth: What Matters Are the Questions Asked, 1 J. Applied Res. Memory & Cognition, 110 (2012)CrossRefGoogle Scholar (recommending deception researchers “stop … trying to find good lie detectors, teaching people to focus on cues that are not really diagnostic, or designing yet another gadget based on the anxiety assumption”).

87 Kassin et al., supra note 84, at 393-94.

88 Kassin, Saul M. et al., “I'd Know a False Confession if I Saw One:” A Comparative Study of College Students and Police Investigators, 29 L. & Hum. Behav. 211, 221-22 (2005)CrossRefGoogle Scholar (finding students more accurate than police, and police more confident and prone to judge confessors as guilty).

89 See, e.g., United States v. Magallanez, 408 F.3d 672, (10th Cir. 2005) (examining whether a witness is credible if there is a significant motive to lie); see also Meixner, John B., Comment, Liar, Liar, Jury's the Trier? The Future of Neuroscience-Based Credibility Assessment in the Court, 106 Nw. U. L. Rev. 1451, 1464 (2012)Google Scholar (“It would be wonderful if judges and jurors were able to determine the credibility of witnesses by carefully staring at the witnesses' shoulders and lower lips during testimony, but an abundance of research into laypeople's and trained individuals' ability to detect lies has shown that people are simply not very good at detecting lies by analyzing demeanor. Additionally, training individuals to look for certain demeanor-based cues does not significantly improve accuracy; in fact, it increases misplaced confidence in one's own abilities to detect lies and leads to a bias toward suspecting others' untruthfulness.”) (footnotes omitted).

90 United States v. Scheffer, 523 U.S. 303, 313 (1998) (citing United States v. Barnard, 490 F.2d 907, 912 (9th Cir. 1973)

91 Scheffer, 523 U.S. at 313 (citing Aetna Life Ins. Co. of Hartford v. Ward, 140 U.S. 76, 88 (1891)) (internal quotations omitted).

92 Baker, Alysha et al., Will Get Fooled Again: Emotionally Intelligent People Are Easily Duped by High-Stakes Deceivers, 18 Legal & Criminological Psychology 300, 308-09 (2013)CrossRefGoogle Scholar.

93 Id. at 309. This is preliminary research but could represent a significant hurdle for already taxed physicians trying to straddle the competing interests and pressures of treating pain and not contributing to diversion.

94 See, e.g., Burcher, Paul, Emotional Intelligence and Empathy: Its Relevance in the Clinical Encounter, 3 Patient Intelligence 23, 27 (2011)CrossRefGoogle Scholar (“For physicians, both emotional intelligence and empathy are crucial.”); see also Stanton, Clive et al., Comparison of Emotional Intelligence Between Psychiatrists and Surgeons, 35 Psychiatrist 124, (2011)CrossRefGoogle Scholar (finding psychiatrists and surgeons had similar composite EI scores but that psychiatrists were significantly higher on emotional awareness and empathy subcategories while surgeons scored higher on self-regard subcategory).

95 See, e.g., Mintz, Laura Janine & Stoller, James K., A Systematic Review of Physician Leadership and Emotional Intelligence, J. Graduate Med. Educ. 1, 21, 22-25 (2014)CrossRefGoogle ScholarPubMed (“Eighty-three articles addressed the theme that EI is a key component of developing medical leaders ….”); Catherine D. Serio & Ted Epperly, Physician Leadership: A New Model for a New Generation, Fam. Practice Mgmt. 51, 52 (2006) (“[S]ucessful leadership stems not from one's IQ but from one's EQ, or emotional intelligence ….”).

96 See, e.g., Bellon, Juan Angel & Fernandez-Asensio, Maria Eugenia, Emotional Profile of Physicians Who Interview Frequent Attenders, 48 Patient Educ. & Counseling 33, 38 (2002)CrossRefGoogle ScholarPubMed (studying the emotional responses of physicians during patient interviews, and finding that 37% of participants responded felt that “I think this person really needs me”); Elder, Nancy et al., How Respected Family Physicians Manage Difficult Patient Encounters, 19 J. Amer. Board Family Med. 533, 535, 538-39 (2006)CrossRefGoogle ScholarPubMed (“The physician participants discussed management strategies that we[re] classified into three categories: collaboration, empathy, and the appropriate use of power.”).

97 See, e.g., Murinson, Beth B. et al., A New Program in Pain Medicine for Medical Students: Integrating Core Curriculum Knowledge with Emotional and Reflective Development, 12 Pain Med. 186, 192 (2011)CrossRefGoogle ScholarPubMed (“[T]he need for improved medical education in pain and pain care is clear ….”).

98 Letter from James L. Madara, Exec. Vice Pres., CEO, American Medical Association, to Thomas Frieden, Dir., CDC (Jan. 12, 2016), http://www.painmed.org/files/ama-letter-to-cdc-proposed-2016-guidelines-for-prescibing.pdf [http://perma.cc/K9W3-WFQC] (emphasis added).

99 See Maia Szalavitz, Here's What's Wrong with How U.S. Doctors Respond to Painkiller Abuse, Pacific Standard (Apr. 22, 2015), http://www.psmag.com/health-and-behavior/heres-whats-wrong-with-how-us-doctors-respond-to-painkiller-misuse [http://perma.cc/DT5Z-Q96B]; see also Sissela Bok, Lying: Moral Choice in Public and Private Life 20 (1978) (“Those who learn that they have been lied to in an important matter … are resentful, disappointed and suspicious…. They see that they were manipulated, that the deceit made them unable to make choices for themselves according to the most adequate information available, unable to act as they would have wanted to act had they known all along.”).

100 See, e.g., Pate Law & Johnson, Page Pate Successfully Resolves Case for Doctor Charged with Operating “Pill Mill”, Our Blog (May 3, 2013), http://www.pagepate.com/our-firm-successfully-resolves-case-for-doctor-charged-with-operating-pill-mill/ [http://perma.cc/B2CK-2TSM] (“The patient files included MRI reports, patient questionnaires, patient charts, and drug tests. The results were clear: Dr. Mintlow was engaged in the legitimate practice of medicine. Our firm also found numerous patients who were more than willing to testify that Dr. Mintlow was an excellent doctor who cared deeply about their health and quality of life.”); see also U.S. Dep't of Justice, Drug Enforcement Agency, Docket No. 13-37, Samuel Mintlow, M.D.: Decision and Order (Dec. 30, 2014), http://www.deadiversion.usdoj.gov/fed_regs/actions/2015/fr0123_2.htm.

101 See, e.g., Pollock, Wendi & Menard, Scott, “It Was a Bum Rap”: Self-Reports of Being Erroneously Arrested in a National Sample, 39 Crim. Just. Rev. 325, 325 (2014)CrossRefGoogle Scholar (“Arrests that are erroneous for any reason are a serious concern in the United States, for both individuals and police departments. For individuals, these actions could cause harms in the form of the possibility of being falsely labeled as a criminal, the loss of family trust, job loss, high financial costs, incarceration, and so on.”) (citation omitted).

102 Brennan, Michael J., Letter to the Editor, 9 Pain Med. 379, 380 (2008)CrossRefGoogle Scholar.

103 Health care in general is one of the most highly regulated industries and all facets of its operation are subject to federal, state, and local law. See Field, Robert I., Why is Health Care Regulation So Complicated?, 33 Pharmacy & Therapeutics 607, 607 (2008)Google Scholar; see, e.g., Bryden, Daniele & Storey, Ian, Duty of Care and Medical Negligence, 11 Continuing Educ. Anesthesia 124 (2011)CrossRefGoogle Scholar (regulating physicians through private negligence actions); Anti-Kickback & Stark Compliance, Am. Acad. of Family Physicians, http://www.aafp.org/practice-management/regulatory/compliance/stark.html (regulating contracts between physicians and other entities) [http://perma.cc/S7TN-Y3L4]; A Roadmap for New Physicians: Fraud and Abuse Laws, HHS, Office of the Inspector General, http://oig.hhs.gov/compliance/physician-education/01laws.asp [http://perma.cc/DV6B-SCTA] (regulating the sector with fraud and abuse laws); Emergency Medical Treatment & Labor Act (EMTALA), Centers for Medicaid & Medicare Services, https://www.cms.gov/Regulations-and-Guidance/Legislation/EMTALA/ [http://perma.cc/JQ6K-XHN8] (regulating treatment); The HIPAA Privacy Rule, HHS, http://www.hhs.gov/hipaa/for-professionals/privacy/ [http://perma.cc/NM9D-MBUM] (regulating the transmission of health information to ensure confidentiality). This article makes no attempt to cover even a fraction of these but will focus primarily on the regulation of the individual provider professional behavior by state medical boards, law enforcement, and the Drug Enforcement Agency, a division of the Department of Justice and the Federal Bureau of Investigation.

104 Johnson, Regulating, supra note 80.

105 Id. at 999-1000 (describing the impact of the penalties of the process as a category of bad law claims that should be taken seriously) (internal quotation marks omitted).

106 See, e.g., Barnes & Sklaver, supra note 25, at 96 (“When a patient dies of a prescription drug overdose, the physician may face legal actions ranging from civil liability to first-degree murder.”).

107 See, e.g., Schneider v. CMS, DAB No. CR3066, 2014 WL 265780 (Departmental App. Bd. Jan. 7, 2014) (affirming CMS's exclusion from participation through revocation of enrollment and billing privileges for failing to report a short term suspension by the Wyoming medical board after a patient died of a mixed drug overdose involving transdermal fentanyl patches prescribed by Dr. Schneider). Conviction of a felony related to controlled substances triggers automatic exclusion from federal and state health care programs and the physicians is thereafter an excluded provider. 42 U.S.C. 1320a-7(a)(4)(2012). In addition, any suspension of a medical license requires the provider to report to the Centers for Medicare and Medicaid Services. 42 C.F.R. § 424.516(d)(1)(ii) (2015).

108 Conviction or guilty pleas of felonies related to controlled substances trigger a cascade of consequences that make it impossible to practice medicine, from excluded provider status to automatic revocation of a DEA certificate of registration to automatic suspension of a medical license. See 42 U.S.C. 1320a-7(a)(4).

109 See, e.g., Agency for Health Care Administration v. Meek, C.I. No. 13-1101-000, at *2-3 (Fla. Div. Admin. Hearings Apr. 7, 2014) (suspending physician's participation in the Florida Medicaid program for ten years after his federal indictment).

110 Meyer, Donald J. & Price, Marilyn, Peer Review Committees and State Licensing Boards: Responding to Allegations of Physician Misconduct, 40 J. Amer. Acad. Psychiatry L. 193 (2012)Google ScholarPubMed (describing the “peer review” process).

111 See, e.g., Arora et al., supra note 43, at 54 (describing the process by which a physician could lose AMA membership as a disciplinary measure).

112 For a basic overview of medical malpractice, including the elements and standard of proof required, see Bal, G. Sonny, An Introduction to Medical Malpractice in the United States, 467 Clin. Orthopedics Related Res. 339 (2008)CrossRefGoogle ScholarPubMed.

113 See, e.g., Fed'n of St. Med. Bds., U.S. Medical Regulatory Trends and Actions 7 (2014), https://www.fsmb.org/Media/Default/PDF/FSMB/Publications/us_medical_regulatory_trends_actions.pdf [http://perma.cc/J26J-47KE] [hereinafter U.S. Medical Regulatory Trends] (“[M]alpractice claims are not always reliable measures of a physician's competence or a violation of the law. Issues such as a physician's time in practice, the nature of his or her specialty, the types of patients treated, and geographic location can have a significant influence on the number and amounts of malpractice judgments and settlements. Malpractice settlements are sometimes handled by insurance companies who opt for settlement based on the terms of coverage, not the validity of the underlying claim. These terms may also authorize settlement of a claim without any consultation of the physician involved or an ultimate determination of fault.”).

114 See, e.g., Stelfox, Henry Thomas et al., The Relation of Patient Satisfaction with Complaints Against Physicians and Malpractice Lawsuits, 118 Amer. J. Med. 1126, 1131 (2005)CrossRefGoogle ScholarPubMed (”[P]hysicians who received low patient satisfaction ratings were more likely to have complains from patients and malpractice lawsuits than those with high ratings. Physicians with high rates of complaints from patients were also more likely to have malpractice lawsuits than were physicians with low rates.”).

115 See, e.g., Hermer, Laura D. & Brody, Howard, Defensive Medicine, Cost Containment, and Reform, 25 J. Gen. Internal Med. 470, 470 (2010)CrossRefGoogle ScholarPubMed (arguing that fear of medical malpractice results in “defensive medicine”).

116 See e.g., Mayer, Gilah A., Comment, Bergman v. Chin: Why an Elder Abuse Case is a Stride in the Direction of Civil Culpability for Physicians Who Undertreat Patients Suffering from Terminal Pain, 37 New Eng. L. Rev. 313 (2002)Google Scholar (discussing Bergman v. Chin, one of the most notable cases where a physician has been found liable for undertreating that resulted in a $1.5 million jury verdict).

117 Johnson, Sandra H., Customary Standards of Care: A Challenge for Regulation and Practice, 43 Hastings Center Rep. 9, 9-10 (2013)CrossRefGoogle ScholarPubMed [hereinafter Johnson, Customary Standards] (noting the difficulty in the reliance on the majority practices and how it can incentive physicians to practice in the “safety of the middle of the herd” rather than employ new evidence based practices or engage in innovation).

118 See id. at 9; see also Zitter, Jay M., Annotation, Physician's Liability for Patient's Addiction to or Overdose from Prescription Drugs, 44 A.L.R. 6th 391, 402-03 (2009)Google Scholar (describing the standard of care, in general terms, as “standard of skill and learning ordinarily possessed and exercised under similar circumstances by physicians in good standing in the same or similar localities”).

119 Brushwood, David B., Debunking Myths of Negligence in Pain Management Practice, 21 J. Pain & Palliative Care Pharmacotherapy 47, 48 (2007)CrossRefGoogle ScholarPubMed.

120 See, e.g., id at 50-52 (discussing a Florida case in which the physician was not found liable for failing to include every possible action listing in the state guideline but showing reasonable attention to the benefits and harms to the patient). There are at least some indications that the legal system governing malpractice is able to discern when medical care is individualized and that it need not include every possible option to protect against liability. See, e.g., Dallaire v. Hsu, No. CV075004043, 2010 WL 2822494, at *7 (Conn. Super. Ct. 2010) (holding failure of physician to follow guidelines to contact previous doctors and pharmacies before prescribing opioids did not constitute a deviation from the standard of care); see, e.g., Brushwood, supra note 119 (discussing a case where the Third District Court of Appeal for Florida recognized that “pain management practice requires doing … things that are appropriate for each patient”).

121 Zitter, supra note 118. These include whether (1) doses were excessive in relationship to the patient's history, (2) prescriptions were written with minimal or no physical exam, (3) the physician warned the patient of dangers, such as polysubstance ingestion, (4) the physician failed to refer the patient to specialty care, (5) the physician failed to give proper weight to the opinions of others, and (6) the physician failed to keep appropriate records. None of them are dispositive alone. See generally id.

122 See, e.g., Rich & Webster, supra note 40, at S62 (“A failure to modify practices recently proven to be ineffective or to pose unacceptable risks to patients can provide the basis of a finding of medical malpractice ….”).

123 In fact, SMBs often weigh the import of malpractice cases based only on patterns. See U.S. Medical Regulatory Trends, supra note 113. One case usually does not warrant action or concern.

124 Bal, Amrit K. & Bal, B. Sonny, Medicolegal Sidebar: State Medical Boards and Physician Disciplinary Actions, 472 Clin. Orthopaedics & Related Res. 28, 31 (2014)CrossRefGoogle ScholarPubMed.

125 See Meyer & Price, supra note 110, at 195, 199 (explaining that state boards are oversight agencies, charged with protecting the public and that the “board's client is the public,” not physicians who are privileged to practice under their authority).

126 Fed'n of State Med. Bds., Essentials of a State Medical and Osteopathic Practice Act 3 (2012) http://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/GRPOL_essentials.pdf [http://perma.cc/YTC5-PX4N] [hereinafter FSMB, ESSENTIALS] (emphasis added, numbers added for clarity).

127 See id. at 3-4.

128 Vulnerable populations in this article means “groups that are not well-integrated into the healthcare system because of ethnic, cultural, economic, geographical, or health characteristics, and whose isolation from health care puts them at risk ….” Lawton, Ellen & Sandel, Megan, Investing in Legal Prevention: Connecting Access to Civil Justice and Healthcare through Medical-Legal Partnership, 35 J. Legal Med. 29, 30 (2014)CrossRefGoogle ScholarPubMed.

129 See Fed'n St. Med. Bds., 2014 Annual Report: Connecting for Success 4-5 (2014), http://www.fsmb.org/Media/Default/PDF/Publications/fsmb-annual-report2014.pdf [http://perma.cc/7LYF-CNGX]; see also FSMB, Essentials, supra note 126, at 4 (“‘Competence’ means possessing the requisite abilities and qualities (cognitive, non-cognitive, and communicative) to perform effectively within the scope of the physician's practice while adhering to professional ethical standards.”).

130 See, e.g., Thompson, James N. & Robin, Lisa A., State Medical Boards: Future Challenges for Regulation and Quality Enhancement of Medical Care, 33 J. Legal Med. 93, 104 (2012)CrossRefGoogle ScholarPubMed (noting that “boards cannot function as police overseeing the practice of medicine. The boards are set up to respond to complaints from individuals or organizations within the state.”).

131 See Johnson, Customary Standards, supra note 117, at 9.

132 See U.S. Medical Regulatory Trends, supra note 113, at 6-7.

133 See, e.g., Khaliq et al., supra note 41, at 776 (indicating the results from their study on which physicians are more likely to be disciplined).

134 See, e.g., Recent Actions, Arizona Board of Osteopathic Examiners in Medicine and Surgery, http://www.azdo.gov/GLSPages/RecentActions.aspx (listing cases of prescribing issues or physicians with substance abuse issues, such as driving under the influence convictions or appearing to work impaired); see Recent Actions, Arizona Board of Allopathic Medicine, Recent Actions, http://www.azmd.gov/GLSPages/RecentActions.aspx.

135 For example, the Federation of State Medical Boards Model Policy on Opioid Use in the Treatment of Chronic Pain emphasizes that “inappropriate treatment [of pain] includes non-treatment, inadequate treatment, overtreatment, and continued use of ineffective treatments.” FSMB, Model Policy on the Use of Opioids, supra note 15, at 7.

136 Hoffmann & Tarzian, supra note 29, at 22.

137 See, e.g., Heumann, Milton et al., Bad Medicine: On Disciplining Physician Felons, 11 Cardozo J. Conflict Resolution 133, 153-167 (2009)Google Scholar (“present[ing] the first-ever comprehensive analysis of the legal and political disciplinary processes for physician felony offenders in the state of New York”).

138 Young, Aaron et al., A Census of Actively Licensed Physicians in the United States, 2012, 99 J. Med. Reg. 11, 14 (2013)Google Scholar (reporting that three-quarters of licensed physicians are board certified).

139 See U.S. Medical Regulatory Trends, supra note 113, at 19 (using the reported numbers of disciplined physicians divided by the total number of licensed physicians in 2012 results in a rate of 0.00510).

140 Id. at 20.

141 See Fla. Dept. of Health, Division of Medical Quality Assurance, 2011-2012 Annual Report and Long Range Plan 18 (2012), http://www.floridahealth.gov/licensing-and-regulation/reports-and-publications/_documents/annual-report-12a.pdf [http://perma.cc/4WSB-9C9Q] (reporting 35/208 complaints resulted in discipline in 2009-10 and 58/207 (28%) in 2011-2012).

142 Bal & Bal, supra note 124, at 29.

143 See U.S. Medical Regulatory Trends, supra note 113, at 57-58. For example, SMBs must report certain actions to the National Practitioner Databank (NPDB). See About Us, National Practtioner Databank, http://www.npdb.hrsa.gov/topNavigation/aboutUs.jsp [http://perma.cc/G4H2-ANQN].

144 U.S. Medical Regulatory Trends, supra note 113, at 9.

145 See, e.g., Kim, Christopher J., The Trial of Conrad Murray: Prosecuting Physicians for Negligent Over-Prescription, 51 Am. Crim. L. Rev. 517, 519 (2014)Google Scholar (“[W]hen a doctor over-prescribes medication, he exposes himself to the danger of criminal liability.”).

146 See, e.g., Mo. Rev. Stat. § 334.103(1) (2008) (creating an automatic revocation upon conviction and conclusion of proceedings for felony involving the practice of medicine, dishonestly, fraud, and moral turpitude, among others).

147 See 21 U.S.C. § 822(a)(2) (2012) The COR is issued by the Attorney General, who heads the Department of Justice, the federal department in which the DEA is situated. See id. The Attorney General is also empowered to deny, revoke, suspend, or limit them through the DEA. 21 U.S.C. § 824 (2012).

148 See, e.g., Hoffmann, Diane, Treating Pain Verses Reducing Drug Diversion and Abuse: Recalibrating the Balance in Our Drug Control Laws and Policies, 1 St. Louis U. J. Health L. & Pol'y 231, 236, 256-57 (2008)Google Scholar [hereinafter Hoffmann, Treating Pain] (“discuss[ing] the ‘culture clash’ … between physicians and drug enforcement personnel”).

149 See id. at 257.

150 See id.

151 See id. at 256-57.

152 See id.

153 See id. Of course, opinions on the utility of opioids vary by physician and by practice area. For example, surgeons generally see opioids as an important component of post-operative acute pain management while those who specialize in addiction medicine may have different views. See, e.g., C. J. Arlotta, Orthopedic Surgeons Largely Contribute to Opioid Epidemic, Study Reveals, Forbes (May 12, 2015), http://www.forbes.com/sites/cjarlotta/2015/05/12/orthopaedic-surgeons-largely-contribute-to-opioid-epidemic-study-reveals/#45eed665636c (“Even though emergency physicians are not likely to prescribe opioids to discharged patients, doctors from other medical fields are contributing to the opioid epidemic at a higher rate.”).

154 For a fascinating account of the early efforts to regulate drugs with the potential for abuse for the benefit of the public health, see Acker, Caroline Jean, Addiction and the Laboratory: The Work of the National Research Council's Committee on Drug Addiction, 1928-1939, 86 Isis 167 (1995)Google ScholarPubMed.

155 Harrison Narcotics Tax Act, Pub. L. No. 63-223, 38 Stat. 785; see also Terry, C. E., The Harrison Anti-Narcotic Act, 5 Amer. J. Pub. Health 518, 518 (1915)CrossRefGoogle ScholarPubMed (criticizing the act as insufficient).

156 § 2(a), 38 Stat. at 786 (requiring new recordkeeping and charting requirements as well). The language of the Controlled Substances Act allows for prescriptions for a “legitimate medical purpose” in the usual course of professional practice, a standard that continues to confound many experts. Controlled Substances Act, Pub. L. 91-513, § 101, § 102, 84 Stat. 1242, 1244 (1970) (codified at 21 U.S.C. §§ 801-904 (2012)).

157 See Cantor, Donald J., The Criminal Law and the Narcotics Problem, 54 J. Crim. L. & Criminology 512, 514 (1961).Google Scholar

158 See, e.g., King, Rufus G., The Narcotics Bureau and the Harrison Act: Jailing the Healers and the Sick, 62 Yale L. J. 736, 736-38 (1953)CrossRefGoogle Scholar (“Our grievous error was in allowing the narcotics addict to be pushed out of society and relegated to the criminal community.”).

159 See, for example, Walter R. Herrick, Second Annual Report of the Narcotic Drug Control Commission 17 (1920) (partly attributing addiction to the fact that “without dispute that the rank and file of medical practitioners in the State are employing narcotics vastly in excess of … legitimate therapeutics”), for an interesting view into the historical attitudes surrounding opioids and substance abuse. See also Stanley, L. L., Morphinism and Crime, 6 J. Crim. L. & Criminology 586, 588 (1916)CrossRefGoogle Scholar (“Physicians of the last decade have been too eager to allay pain merely by slight injection of morphine … with the result that people … have been unwittingly put under the defiling influence of the drug.”).

160 See, e.g., Volkow, Nora D. et al., Medication-Assisted Therapies—Tackling the Opioid--Overdose Epidemic, 370 New Eng. J. Med. 2063 (2014)CrossRefGoogle ScholarPubMed (describing the difficulties in treating opioid addiction); see also Neilsen, Suzanne et al., Buprenorphine Pharmacotherapy and Behavioral Treatment: Comparison of Outcomes Among Prescription Opioid Users, Heroin Users and Combination Users, 48 J. Substance Abuse Treatment 70 (2015)CrossRefGoogle Scholar (studying the effectiveness of buprenorphine in prescription opioid uses); Potter, Jennifer Sharpe et al., The Multi-Site Opioid Addiction Treatment Study: 18-Month Outcomes, 48 J. Substance Abuse Treatment 62 (2015)CrossRefGoogle ScholarPubMed (studying “long-term response to treatment of opioid addiction).

161 See King, supra note 158. Even in the early 1950s, scholars acknowledged that criminal punishment was an insufficient deterrent to drug crimes. See, e.g., Pescor, M. J. The Problem of Narcotic Drug Addiction, 43 J. Crim. L. & Criminology 471, 478 (1953)Google Scholar.

162 See King, supra note 158, at 738.

163 Some states require newly licensed providers to obtain authority through a separate state agency such as a state board of pharmacy. In those states, the DEA requires proof that such state authorization exists before issuing a COR. See, e.g., DEA Form 224-New Application for Registration, U.S. Dep't of Justice, Drug Enforcement Agency, Division of Diversion Control, http://www.deadiversion.usdoj.gov/drugreg/reg_apps/224/224_instruct.htm [http://perma.cc/6L3L-9UG6] (Section 4 addresses the interaction between the DEA and the state).

164 See U.S. Medical Regulatory Trends, supra note 113, at 74.

165 See id.

166 Infra Part III.C.1.

167 Federal Food, Drug, & Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301-399d (2012)).

168 See FDA, A History of Drug Regulation in the United States 7 (2006), http://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/UCM114468.pdf [http://perma.cc/CH59-Q3ZZ] [hereinafter History of Drug Regulation] (The Durham Humphrey Amendments of 1951 “identified fairly clear parameters for what constitutes a prescription drug”).

169 Id. at 2.

170 See id. at 14.

171 Drug Amendments of 1962, Pub. L. No. 87–781, § 102(a)(1), 76 Stat. 780, 782-83 (Oct. 10, 1962).

172 See, e.g., Understanding Investigational Drugs and Off Label Use of Approved Drugs, FDA. (Feb. 5, 2016), http://www.fda.gov/forpatients/other/offlabel/default.htm [http://perma.cc/9KRV-CFJT] (providing information about the labeling and use of off-label drugs).

173 See, e.g., FDA, Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) 2 (2015), http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf (“The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting (ER/LA) opioid analgesics while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death.”). The FDA's ability to impose REMS was the result of the 2007 Food and Drug Administration Amendments Act. FDAAA Implementation – Highlights One Year After Enactment Summary, FDA (Apr. 27, 2009), http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm083161.htm [http://perma.cc/A5AE-YYNS].

174 See 21 U.S.C. §§ 811-12 (2012); see also Scheduling of Drugs Under the Controlled Substance Act, FDA, http://www.fda.gov/newsevents/testimony/ucm115087.htm [http://perma.cc/QVP4-YDGU] (discussing the FDA's role in the scheduling process and specifically addressing three drug substances of interest at the time of the statement's release).

175 Controlled Substances Act, Pub. L. No. 106-172, §§ 6, 7, 114 Stat. 11 (2000) (as amended by Pub. L. 111-8, div. G, title I, § 1301(d), 123 Stat. 829 (2009)). The Comprehensive Drug Abuse and Prevention & Control Act of 1970 established requirements related to the manufacture, prescription, and distribution of any controlled substance. 21 U.S.C. § 801. It also provides procedural requirements for the Attorney General to follow regarding scheduling of drugs. 21 U.S.C. § 811.

176 21 U.S.C. § 331.

177 Id. § 333(a)(1).

178 21 U.S.C. § 353(b); see also United States v. Nazir, 211 F. Supp. 2d 1372, 1377 (S.D. Fla. 2002) (“[T]he word ‘prescription’ cannot be defined as mere piece of paper signed by a doctor for drugs, no matter how fraudulent.”).

179 Id. §§ 801-904

180 Id. § 812(b).

181 Id. § 812(b)(1)(A)-(B). Schedule I drugs can only be used by providers subject to specific permissions for use in research and include drugs such as heroin, LSD, and crack cocaine. See 21 C.F.R. § 1308.11 (2015).

182 21 U.S.C. § 812(b)(2)-(5).

183 21 C.F.R. § 1308.12. Until October 2014, hydrocodone with Tylenol was a schedule III drug also. See also Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II, 79 Fed. Reg. 49,661, 49,662 (Aug. 22, 2014) (to be codified at 21 C.F.R. pt. 1308).

184 See, e.g., Zhong, Wenjun et al., Age and Sex Patterns of Drug Prescribing in a Defined American Population, 88 Mayo Clinic Proc. 697, 704 (2013)CrossRefGoogle Scholar.

185 21 C.F.R. § 1308.13.

186 21 C.F.R. § 1308.14. It is worth noting, however, that benzodiazepines are implicated in almost a third of prescription drug overdoses. Prescription Drug Overdose Data: Deaths from Prescription Opioid Overdose, CDC (Oct. 16, 2015), http://www.cdc.gov/drugoverdose/data/overdose.html [http://perma.cc/C79H-CXM8].

187 21 U.S.C. § 841(a) (emphasis added).

188 Id. § 846; see id. § 841(b) for the penalties of such an offense.

189 Id. § 829. Although not directly applied to in-person prescribing, a 2008 Amendment to the CSA added that “[t]he term ‘valid prescription’ means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by … a practitioner who has conducted at least 1 in-person medical evaluation of the patient ….” Ryan Haight Online Pharmacy Consumer Protection Act of 2008, Pub. L. No. 110-425, § 309, 122 Stat. 4820 (2008) (emphasis added).

190 21 C.F.R. § 1306.04(a).

191 See 21 U.S.C. §§ 353(b), 802(21), 829(b).

192 See, e.g., United States v. Boccone, 556 F. App'x. 215, 228 (4th Cir. 2014) (explaining that conviction under CSA requires the government to show that a practitioner “distributed or dispensed a controlled substance … acted knowingly and intentionally, … [and that the practitioner's] actions were not for legitimate medical purposes in the usual course of his professional medical practice or were beyond the bounds of medical practice”) (internal quotation marks omitted). See, e.g., United States v. Moore, 423 U.S. 122, 131-33 (1975) (holding that the possession of a COR is not a protection either United States v.).

193 Gonzales v. Or., 546 U.S. 243, 274 (2006).

194 Barnes & Sklaver, supra note 25, at 103.

195 See, e.g., Model Penal Code § 2.01, 2.02(2) (Am. Law Inst., Proposed Official Draft 1962) (containing four types of mens rea: (1) purposely (conscious and intentional acts with hope of result); (2) knowingly (knowledge that act is criminal and is practically certain of result); (3) recklessly (conscious disregard and gross deviation from law abiding standard of conduct); and (4) negligently (failure to perceive a risk such that it is a gross deviation from law abiding conduct)).

196 21 U.S.C. § 841(a).

197 21 C.F.R. § 1306.04 (2015).

198 See, e.g., Kim, supra note 145, at 527-28 (discussing United States v. Wood, and its effect of increasing “government interest in prosecuting doctors for involuntary manslaughter”).

199 Id. at 532 (quoting Criminal Negligence, Black's Law Dictionary (10th ed. 2014)).

200 United States v. Katz, 445 F.3d 1023, 1031 (8th Cir. 2006).

201 From, Justin C., Note, Avoiding Not-So-Harmless Errors: The Appropriate Standards for Appellate Review of Willful-Blindness Jury Instructions, 97 Iowa L. Rev. 275, 281 (2011)Google Scholar (further discussing that the willful blindness theory is not limited to the CSA as it applies to many criminal causes of action (including other white collar crimes), and that it is sometimes it is used to equate one's mental state to recklessness and sometimes to knowledge.

202 See, e.g., Hellman, supra note 74, at 716 (describing a case in which the government relied on circumstantial evidence to argue that a physician willfully blinded himself). A common example of willful blindness in CSA violations is a drug runner who demands not to be told what is contained in the transported packages. von Kaenel, Frans J., Willful Blindness: A Permissible Substitute for Actual Knowledge Under the Money Laundering Control Act?, 71 Wash. U. L. Q. 1189, 1199 n.61 (1993)Google Scholar.

203 Katz, 445 F.3d. at 1031.

204 Id. (upholding the willful blindness jury instruction as proper).

205 See generally Dispensing Controlled Substances for the Treatment of Pain, 71 Fed. Reg. 52,716 (Sept. 6, 2006) (responding to questions related to the role of the DEA in regulating the prescribing of controlled substances and the ways in which law enforcement may find that a physician prescribed or dispensed controlled substances for other than a legitimate medical purpose).

206 Recall that civil liability in medical malpractice can result from even one deviation from the standard of care and professional discipline usually requires some degree of pattern of inappropriate practice. See McCourt v. Abernathy, 457 S.E.2d 603, 607-08 (S.C. 1995) (holding physicians liable for failing to diagnose and treat patient within standard of care). Civil liability, however, involves loss of money and status but not loss of basic civil rights and freedoms. See, e.g., id. (affirming the jury's determination of damages).

207 See, e.g., Dispensing Controlled Substances for the Treatment of Pain, 71 Fed. Reg. 52, 716, 52, 719 (Sept. 6, 2006) (“Throughout the 90 years that this requirement has been a part of United States law, the courts have recognized that there are no definitive criteria laying out precisely what is legally permissible, as each patient's medical situation is unique and must be evaluated based on the entirety of the circumstances. DEA cannot modify or expand upon this longstanding legal requirement through the publication or endorsement of guidelines.”); see also, Barnes & Sklaver, supra note 25, at 95-97; Brushwood, David B., Defining “Legitimate Medical Purpose” 62 Am. J. Health-Sys. Pharmacy 306, 307 (2005)CrossRefGoogle ScholarPubMed (arguing that the standard should be understood as without a “medical purpose” to properly protect physician good faith treatment decisions from criminal scrutiny).

208 See, e.g., United States v. Boccone, 556 Fed. App'x. 215, 229 (4th Cir. 2014) (holding that “‘there are no specific guidelines concerning what is required to support a conclusion that an accused acted outside the usual course of professional practice,’ and that the court ‘must engage in a case-by-case analysis of evidence to determine whether a reasonable inference of guilt may be drawn from specific facts.’”) (quoting United States v. Singh, 54 F.3d 1182, 1187 (4th Cir. 1995).

209 See, e.g., United States v. Feingold, 454 F.3d 1001, 1007 (9th Cir. 2006) (“[O]nly after assessing the standards to which medical professionals generally hold themselves is it possible to evaluate whether a practitioner's conduct has deviated so far from the [standard of care] ….”).

210 Id. (emphasis in original).

211 United States v. MacKay, 20 F. Supp. 3d 1287, 1297 (D. Utah 2014).

212 See Hoffmann, Diane E., Physicians Who Break the Law, 53 St. Louis U. L.J. 1049, 1079-84 (2009)Google Scholar [hereinafter Hoffmann, Break the Law]; see also Hoffmann, Treating Pain, supra note 148, at 239-42 (citing to cases such as the one against Dr. Frank Fisher, who spent 5 months in jail before his charges were reduced).

213 See, e.g., United States v. Kaplan, 895 F.2d 618, 620-21 (9th Cir. 1990) (issuing numerous prescriptions for controlled substances without a documented physical exam of the patients is evidence of conduct “outside the course of usual professional practice”); United States v. Nelson, 383 F.3d 1227 (10^th Cir. 2004) (physician convicted for selling prescriptions over the internet); United States v. Rosen, 582 F.2d 1032 (5th Cir. 1978) (noting that no physical examination, large numbers of amphetamine prescriptions, and use of “street slang” in reference to the drugs was sufficient to determine the doctor acted without a legitimate medical purpose).

214 See Brief for Defendant at 8, United States v. MacKay, 2011 WL 10723623 (D. Utah 2011) (No. 110CR00094) (“It is dangerous in close cases to require juries to determine if a physician is a criminal based on a deviation of undefined measure from a civil standard.”); Hoffmann, supra note 212, at 1080 (“In addition to the arrests and prosecutions of physicians for fraud, scores of physicians are being arrested and prosecuted for drug abuse and diversion based on a standard that is ‘uncomfortably close’ to a civil malpractice standard.”). But see Barnes & Sklaver, supra note 25, at 104 (“Physicians can meet these duties under the CSA by abiding by the medical standard of care. Although the CSA test is used for criminal liability, it is consistent with the medical standard of care, and courts have applied both the reasonable, prudent physician and medical customs tests in CSA cases.”) (footnote omitted).

215 See United States v. Schneider, 704 F.3d 1287, 1301 (10th Cir. 2013) (holding the good faith instruction at the trial level was not in error) (internal quotation marks omitted); see also Goodman, Katherine, Note, Prosecution of Physicians as Drug Traffickers: The United States' Failed Protection of Legitimate Opioid Prescription Under the Controlled Substances Act and South Australia's Alternative Regulatory Approach, 47 Colum. J. Transnat'l L. 210, 214 (2008)Google Scholar (“[I]n most circuits, a physician's good faith in treating his patients presents no bar to conviction unless he purposely complied with objectively accepted, standard medical guidelines.”).

216 21 U.S.C. § 841(b) (2012); see also United States v. Ilayayev, 800 F. Supp. 2d 417, 434-43 (E.D.N.Y. 2011) (providing an excellent overview of the pressures faced by physicians and the obligations of law enforcement).

217 Ilayayev, 800 F. Supp. 2d at 434.

218 21 U.S.C. 841(b).

219 See, e.g., United States v. Paul Volkman, 736 F.3d 1013 (6th Cir. 2013) (affirming a physician's sentence of four consecutive life terms for violations of the CSA leading to the deaths of four patients); United States v. Joseph, 709 F.3d 1082 (11th 2013) (affirming one doctor's thirty-year prison sentence for “unlawfully dispensing or distributing controlled substances and causing death or serious bodily injury”); United States v. Webb, 655 F.3d 1238 (11th 2011) (affirming several concurrent life sentences for misprescribing leading to patient deaths).

220 See Joseph, 709 F.3d at 1092 (emphasis added)(internal quotation marks omitted) (quoting 21 U.S.C. § 841(b)(1)(C)).

221 Burrage v. United States, 134 S. Ct. 881, 887 (2014). Prior to the Burrage decision, physician defendants faced the twenty-year mandatory sentence if the prescription contributed to the patient's death. See United States v. MacKay, 20 F. Supp. 3d 1287 (D. Utah 2014) (reducing MacKay's sentence on remand following the Burrage decision from 240 months of incarceration to 36 months).

222 See Kim, supra note 145 (providing a comprehensive overview of criminal medical negligence actions for over-prescription).

223 See, e.g., Mintlow, Samuel M.D.; Decision and Order, 80 Fed. Reg. 3,630, 3,631 (Jan. 23, 2015)Google Scholar (revoking his DEA COR even though the SMB did not take action against him). Most states have state boards of pharmacy or bureaus of narcotics that authorize prescribing of controlled substances at the state level. See, e.g., Joint State Government Commission: General Assembly of the Commonwealth of Pa., House Resolution 659: Report of the Task Force and Advisory Committee on Opioid Prescription Drug Proliferation 76 (2015) (“The Advisory Committee supports passage of House Bill 75 of 2015 (P.N. 66), which would require nonresident (out-of-state) pharmacies to register biennially with the State Board of Pharmacy to be permitted to fill prescription orders for Pennsylvania residents.”). An administrative action at one level will often automatically trigger parallel proceedings to sanction, suspend, or revoke the prescriber's authority. See e.g., Barbara Anderson, Fresno Psychiatrist Faces Disciplinary Action by Medical Board in Second Patient Death, Fresno Bee (Feb. 21, 2015), http://www.fresnobee.com/news/local/article19536294.html [http://perma.cc/6ZYV-QW44] (after being accused of gross negligence by the Medical Board of California, the physician's license was revoked).

224 See generally Mulrooney, John J. II & Hull, Andrew J., Drug Diversion Administrative Revocation and Application Hearings for Medical and Pharmacy Practitioners: A Primer for Navigating Murky, Drug-Infested Waters, 78 Alb. L. Rev. 327 (2015)Google Scholar (providing an excellent and detailed description of the administrative process and the standards by which actions for revocation are measured).

225 21 U.S.C. § 824(a)(1) (2012).

226 Id. § 824(a)(2).

227 Id. § 824(a)(3).

228 Id. § 824(a)(4).

229 Id. § 824(a)(5).

230 Id. § 823(f) (Factors include the recommendations of the SMB, the physician's experience with controlled substances, convictions of any laws related to controlled substances, compliance with controlled substances laws, or any other conduct that threatens public health.).

231 See Dewey C. Mackay, M.D.; Revocation of Registration, 75 Fed. Reg. 49,956, 49,973 (Aug. 16, 2010) (“I ‘may rely on any one or a combination of factors, and may give each factor the weight [I] deem[] appropriate in determining whether a registration should be revoked.’”) (quoting Robert A. Leslie, M.D., 68 Fed. Reg. 15,227, 15, 230 (2003)).

232 United States v. Feingold, 454 F.3d 1001, 1007 (9th Cir. 2006). The DEA must find that “the practitioner's conduct went ‘beyond the bounds of any legitimate medical practice, including that which would constitute civil negligence.’” Samuel Mintlow, M.D.: Decision and Order, 80 Fed. Reg., at 3648 (quoting Laurence T. McKinney, 73 Fed. Reg. 43,260, 43,266 (2008) (quoting United States v. McIver, 470 F.3d 550, 559 (4th Cir. 2006)) (internal quotation marks omitted).

233 See Dewey C. MacKay, M.D.; Revocation of Registration, 75 Fed. Reg., at 49,977 (“[T]he Agency has revoked other practitioner's registration for committing as few as two acts of diversion, and the Agency can revoke based on a single act of intentional diversion.”) (citation omitted).

234 Mulrooney & Hull, supra note 224, at 327-28 (emphasis added) (“The prevalence of prescription controlled substance abuse has grown exponentially over the past decade. State and federal regulatory agencies have struggled to adjust to the changing realities of a new challenge and a new dynamic between the regulators and the regulated community…. [T]hese efforts have also left many responsible professionals in the regulated community scrambling to understand new realities”).

235 The chilling effect was described as a myth by the DEA and researchers have asserted that the risks are very small. Press Release, DEA, The Myth of the “Chilling Effect” (Oct. 30, 2003), http://www.dea.gov/pubs/pressrel/pr103003.html [http://perma.cc/ZTX6-RAJ3]. Nonetheless, providers continue to report fears of investigation and prosecution. See, e.g., Reidenberg & Willis, supra note 71 (finding a reduction in the prescription of opioids due to fear of legal action).

236 Alicia Gallegos, Physician Liability: When an Overdose Brings a Lawsuit, Am. Med. News (Mar. 4, 2013), http://www.amednews.com/article/20130304/profession/130309978/4/ [http://perma.cc/28N4-3BMD] (quoting health law attorney Michael A. Moroney).

237 See, e.g., Anderson, supra note 223 (describing the story of a physician who “was placed on probation six years ago for a patient death [who] now faces new disciplinary action by the Medical Board of California for a second death.”).

238 See, e.g., FoxNews, CA Doctor Ordered to Trial in 3 Drug Deaths (June 26, 2012), http://www.foxnews.com/us/2012/06/26/trial-decision-due-for-ca-doctor-in-drug-deaths/ [http://perma.cc/XD8E-KMVL] (describing the story of a physician who was charged with second-degree murder after “prescribing pain killers to three young me who died”).

239 See, e.g., Reidenberg & Willis, supra note 71, at 905 (explaining that these prosecutions “contribute[] to physicians' fear of prescribing opioids”). This may, of course, also simply be a function of the CSA and the specific provisions regarding death or serious harm, which provide prosecutors with an explicit statutory violation to pursue.

240 United States v. Morton Salt Co., 338 U.S. 632, 642-643 (1950) (“[An administrative agency's power] is more analogous to the Grand Jury, which does not depend on a case or controversy for power to get evidence but can investigate merely on suspicion that the law is being violated, or even just because it wants assurance that it is not.”).

241 See, e.g., Dispensing Controlled Substances for the Treatment of Pain, 71 Fed. Reg. 52,716, 52,719 (Sept. 6, 2006) (citing the rate at which physicians in the United States have lost their DEA registration status at 0.01% in any year, fewer than 1 out of 10,000 physicians).

242 Id. at 52,717.

243 See, e.g., Hoffmann, Treating Pain, supra note 148 at 239-56 (profiling cases in which prosecutions were inappropriate).

244 Ziegler, Stephen, & Lovrich, Nicholas P. Jr., Pain Relief, Prescription Drugs, and Prosecution: A Four-State Survey of Chief Prosecutors, 31 J.L., Med. & Ethics 75, 79, 83 at Tbl. 2 (2003)CrossRefGoogle ScholarPubMed (studying prosecutor attitudes in Connecticut, Maryland, Oregon, and Washington regarding pain medication prescriptions and diversion).

245 Id. at 86.

246 Id. at 82-83 Tbl. 3.

247 Id. at 88. Data regarding the rate of addiction within the population of patients receiving opioids on a chronic basis is extremely variable and context dependent. Id. Exposure alone to opioids does not create addiction, as is evidenced by the thousands of tons of unused opioids collected in medication take backs across the country. Lewis et al., supra note 21. That is also evidence that physicians generally prescribe more pain pills than most people need for acute pain.

248 Id. at 87 (explaining that decisions about charging depended upon whether the board handled it appropriately, failed to take appropriate action, or whether they are currently investigating the case).

249 Id. at 93-94.

250 See, e.g., Fed'n St. Med. Bds., Policy Brief: Balance, Uniformity and Fairness: Effective Strategies for Law Enforcement for Investigating and Prosecuting the Diversion of Prescription Pain Medications While Protecting Appropriate Medical Practice (2009), http://www.fsmb.org/Media/Default/PDF/Publications/pub_bbpi_policy_brief.pdf [http://perma.cc/WF2G-KCJF] (providing information “to ensure that patients who need pain medications have access, and to prevent these drugs from becoming a source of harm and abuse”).

251 See Rannazzisi, supra note 56, at 8-9.

252 Id. (noting at page 8 that between 2008 and 2011, inspections increased 528% and administrative actions increased 87%).

253 See Kim, supra note 145, at 535.

254 See United States v. Ilayayev, 800 F. Supp. 2d 417, 434 (E.D.N.Y. 2011) (citing Christine Gorman et al., The Case for Morphine, Time (Apr. 28, 1997)) (“identifying Tennessee, West Virginia, and New York as those states whose review boards are ‘notorious’ for revoking … licenses”).

255 Pollack, supra note 13.

256 See, e.g., Gatchel, Robert J., Is Fear of Prescription Drug Abuse Resulting in Sufferers of Chronic Pain Being Undertreated? 10 Expert Rev. Neurotherapeutics 637, 638 (2010)CrossRefGoogle ScholarPubMed (citing to physician surveys to conclude that “many physicians have their limited pain medication prescriptions due to fear of regulatory investigation.”); see also Szalavitz, supra note 99.

257 Millard, William B., Grounding Frequent Flyers, Not Abandoning Them: Drug Seekers in the ED, 49 Annals of Emergency Med. 481, 481 (2007)CrossRefGoogle Scholar; see also Reidenberg & Willis, supra note 71, at 905 (discussing physicians' fear of prescribing opioids due to criminal prosecutions).

258 Drummond, supra note 69, at 134; see McLellan et al., supra note 25, at 2-3.

259 This is a significant problem already because the treatment of SUD has been unfortunately walled off through practice and regulation leaving many, if not most, physicians untrained or undertrained in recognizing possible SUD and unequipped to guide patients in this area. For an excellent discussion of this underlying problem, see Weber, Ellen M., Failure of Physicians to Prescribe Pharmacotherapies for Addiction: Regulatory Restrictions and Physician Resistance, 13 J. Health Care L. & Pol'y 49 (2010)Google Scholar.

260 See Drummond, supra note 69, at 134 (“[E]ven within the medicalization narrative, the active addict, and to a lesser degree, the recovering addict, is still a socially deviant figure, morally suspect whilst operating under the influence and a dangerous figure even in recovery because of the risk of ‘relapse.’”).

261 Drummond, supra note 69.

262 Id. at 126.

263 Id. at 131.

264 See, e.g., Anna Phillips, Tampa Pill Mill Owners, Manager Sentenced to 30 Years, Get Huge Fines, Tampa Bay Times (Sept. 19, 2014), http://www.tampabay.com/news/courts/criminal/pain-clinic-owners-sentenced-to-30-years-in-prison/2198509 [http://perma.cc/WS57-FN7G] (discussing the prosecution of a “couple [who allegedly] use[ed] their licensed pain clinic as a front to sell thousands of prescriptions to opioid addicts”); Press Release, United States Attorney's Office Northern District of Florida, Pain Clinic Owner and Two Physicians Sentenced for Prescription Drug Conspiracy and Money Laundering Conspiracy (Jan. 18, 2013), http://www.justice.gov/usao-ndfl/pr/pain-clinic-owner-and-two-physicians-sentenced-prescription-drug-conspiracy-and-money [http://perma.cc/9F3D-GH53] (discussing the sentencing of physicians for “running illegal pill mill pain clinics”).

265 See, e.g., Brown v. CVS Pharmacy, L.L.C., 982 F. Supp. 2d 793, 802-03 (M.D. Tenn. 2013) (detailing the recent history of Tennessee's restrictions on opioid prescribing and pain management clinics as evidence that prescribing controlled substances is a matter of public concern); Lynn Webster, When Prosecution Replaces Prescription, Pain Med. News 1, 1 (Aug. 5, 2014) (noting that “the federal government has moved aggressively to regulate, restrict and monitor the use of painkillers”).

266 See Stephanie Smith, Prominent Pain Doctor Investigated by DEA After Patient Deaths, CNN (Dec. 20, 2013), http://www.cnn.com/2013/12/20/health/pain-pillar/.

267 DEA Ends Investigation of Pain Doctor, DrLynnWebster, http://www.lynnwebstermd.com/dea-ends-investigation-of-pain-doctor/ [http://perma.cc/XJ88-2NWQ].

268 Id. (“Actions like these clearly create a chilling effect. There is no false narrative.”).

269 See e.g., Goldenbaum et al., supra note 44 (pain specialty not disproportionately represented); DuBois et al., supra note 51 (“[t]his article advances understanding of improper prescribing of controlled substances”).

270 Notable cases such as that of Dr. William Hurwtiz and Dr. Frank Fisher are described in multiple articles. See Hoffmann, Treating Pain, supra note 148; Hoffmann, Break the Law, supra note 212. A more recent case is that of Dr. Daniel Baldi, a pain specialist who was ultimately acquitted on all criminal charges. See Tony Leys, Baldi, Acquitted on All Charges, Wants to Return to Work, Des Moines Register (May 2, 2014), http://www.desmoinesregister.com/story/news/crime-and-courts/2014/05/01/baldi--verdict-jury/8576229/ [http://perma.cc/5HTV-QCAF]; Iowa Bd. Med., In the Matter of Daniel J. Baldi, D.O., Respondent, Stipulated Order-Agreement not to Practice Medicine, http://medicalboard.iowa.gov/Legal/Baldi,DanielJ.,D.O.-03-09-653,03-12-041.pdf [http://perma.cc/U3R8-69YL].

271 What does exist focuses on either sex crimes or capital crimes. See Menard, Scott & Pollock, Wendi, Self Reports of Being Falsely Accused of Criminal Behavior, 35 Deviant Behav. 378, 378 (2014)CrossRefGoogle Scholar.

272 Id. at 379.

273 See Menard & Pollock, supra note 271, at 378-79 (explaining that false labeling can lead to false accusations and even eventual actual deviance as a result of the continued stigmatization).

274 Dept. of Health v. Roggow, CASE NO. 2009-22381 (State of Fl. Bd. of Osteopathic Med. Jan. 11, 2011) (administrative complaint) (“On or about March 9, 2010, the Department received information from a pharmacist in the Fort Myers area that Respondent appeared to be prescribing excessive quantities of controlled substances. The allegations were supported by pharmacy records indicating numerous patients of Respondent were receiving large quantities of controlled substances.”); see also Dr. Acquitted by Federal Jury Speaks to NBC2, NBC-2 News (June 29, 2012), http://www.nbc-2.com/story/18918407/dr-acquitted-by-federal-jury-speaks-to-nbc2 [http://perma.cc/29CF-SQBU] (“[T]he government's evidence centered mainly on the volume of pills prescribed by Dr. Roggow.”).

275 This was an operation by the tactical diversion squad of the DEA. Tom Brennan, Attorney General in Florida to Discuss Prescription Drug Abuse, Tampa Tribune (Oct. 28, 2011), http://tbo.com/news/crime/attorney-general-in-tampa-to-discuss-prescription-drug-abuse-298876 [http://perma.cc/XP9H-KGPN].

276 NBC-2 News, supra note 274; see Aisling Swift, South Fort Myers Doctor Acquitted of Illegally Prescribing Pain Killers, Naples News (June 28, 2012), www.naplesnews.com/news/local/south-fort-myers-doctor-acquitted-of-illegally-prescribing-pain-killers-ep-388531341-342486082.html [http://perma.cc/D3EB-WEMJ].

277 Jennifer Bolen, Board Certified Doctor Cleared of Criminal Charges for High-Dose Opioid Prescribing, Practical Pain Mgmt. (Aug. 31, 2012), ttp://www.practicalpainmanagement.com/resources/ethics/board-certified-doctor-cleared-criminal-charges-high-dose-opioid-prescribing [http://perma.cc/SV4C-XFYH].

278 While those outcomes are favorable, the charge and embroilment with the legal system can still effectively end a practice. See, e.g., Leys, supra note 270 (case of Daniel Baldi. who was acquitted).

279 See, e.g., Hoffmann, Treating Pain, supra note 148, at 233 (“In a number of troubling cases, however, the physicians arguably were wrongly charged. While some of these providers ultimately were exonerated through acquittal or appeal, their careers, and in many cases their personal lives, were destroyed.”).

280 See Gatchel, supra note 256, at 639 (explaining that opiophobia can lead to undertreatment of pain medication).

281 Kim, supra note 145, at 537 (explaining that relying on SMBs and civil actions have proven inadequate and, “physician self governance has not risen to the occasion”).

282 Heumann et al., supra note 137, at 134, 161 (reporting on qualitative research with attorneys for physicians accused of felonies and reporting an upward trend in drug related felonies between 1990 and 2007 in New York).

283 Supra Part II.B.

284 For example, the FSMB's Model Policy on Opioid Use lists several procedural failures that should be considered inappropriate practice, including: failures to adequately assess the patient, failure to monitor response, and inadequate patient education. FSMB Model Policy, supra note 15 at 5-6.

285 See, e.g., United States v. Volkman, 797 F.3d 377, 384 (6th Cir. 2015) (explaining that a physician whose license was ultimately revoked for misprescribing had little to no oversight). Physicians in this category are often practicing in solo practices or in small groups and not in academic centers in which, for example, residents would also be involved in patient care. DuBois et al., supra note 51.

286 In this and the other examples we use in the remainder of the paper, we relied on facts as presented in published court or administrative agency opinions and sometimes in news reports. We acknowledge these sources do not include a full accounting of the story surrounding the events in question.

287 Jarrott v. La. St. Bd. of Med. Exam'rs, 19 So. 3d 526 (4th Cir. 2009) (affirming the civil district court's decision to uphold the decision of the board for a two year suspension, prohibition of practice in pain management, and $5,000 fine).

288 Id. at 529-31. These kinds of procedural care failures match the kinds of guidelines often used by SMBs such as those listed in the FSMB's Model Policy. See FSMB Model Policy, supra note 15, at 14.

289 Jarrott, 19 So. 3d at 540-41.

290 Id. at 541-46.

291 Id. at 530-31.

292 Id. at 545.

293 Id. at 531.

294 See, e.g., David A. Ruben, M.D.; Decision and Order, 78 Fed. Reg. 38,363, 38,370 (June 26, 2013) (suspending physician's COR for one year after a pattern of prescribing to patients with positive drug screens, after being informed they had completed opioid addiction treatment, were under the care of another physician for addiction, and for failing to document appropriate physical, histories, or prescriptions); see also Jerry Germroth, M.D., No. 0101-034309, 2013 WL 7205090 (Va. Bd. Med. Dec. 17, 2013) (permanently prohibiting physician from prescribing schedule II-III controlled substances and ordering physician to complete continued medical education).

295 See, e.g., id.; see also Nibedita Mohanty, No. 0101-045978, 2013 WL 5592614 (Va. Bd. Med. Sept. 25, 2013) (co-prescribing high doses of Oxycodone products and Dilaudid).

296 These are typically not failures that rely on sophisticated medical judgments or behavior that might be described as judgment calls. These are failures to conform to basic procedural care requirements such as taking histories, checking medical records from recent hospitalizations, and documenting responses to medications.

297 See supra Part II.B.

298 Chuck Klosterman, Bad Decisions: Why AMC's Breaking Bad Beats Mad Men, The Sopranos, and The Wire, Grantland (Aug. 2, 2011), http://grantland.com/features/bad-decisions/ [http://perma.cc/9R9R-9B7E].

299 See, e.g., PA Psychiatrist Arrested for Over-Prescribing, Trading Opioid-Addiction Treatment Drugs for Sex, Gant News (Aug. 20, 2013), http://gantdaily.com/2013/08/20/pa-psychiatrist-arrested-for-over-prescribing-trading-opioid-addiction-treatment-drugs-for-sex [http://perma.cc/L486-939L] (reporting psychiatrist who exchanged sex for controlled substances, charged only cash but also double billed insurance companies); Michael Sadowski, Accused Prescription-Selling New Cumberland Doctor Faces New Drug Charges, Cent. Pa. Bus. J. (Dec. 16, 2014), http://www.cpbj.com/article/20141216/CPBJ01/141219783/Accused-prescription-selling-New-Cumberland-doctor-faces-new-drug-charges [http://perma.cc/X3JL-38SF] (reporting new drug charges against a physician selling prescriptions at convenience stores, his house, and other public areas); Press Release, The United States Attorney's Office Southern District of Georgia, Georgia Doctor Sentenced To 20 Years In Prison For Operating Pill-Mill Clinics (Aug. 8, 2014), http://www.justice.gov/usao-sdga/pr/georgia-doctor-sentenced-20-years-prison-operating-pill-mill-clinics [http://perma.cc/6D9X-NEE4] (doctor collected half a million dollars in cash for prescriptions, used proceeds, in part to buy himself a Ferrari).

300 See, e.g., United States v. Bourlier, No. 11-15268, at *5 (11th Cir. 2013) (along with other evidence that the physician knew or should have known of patients with SUD was the fact that “some family members had called … to ask [the physician] to stop writing prescriptions for addicted patients”).

301 E.g., Paula Mcmahon, South Florida Pill Mill Trial Stars Hidden Cameras, Security Video, Doctors' Own Words, Huffpost Miami (July 6, 2013, 3:32 AM), http://www.huffingtonpost.com/2013/07/06/south-florida-pill-mill_n_3553196.html [http://perma.cc/8C4V-8KQB] (explaining that undercover federal agents went to “pill mills” and “posed as patients”).

302 Shepherd, Joanna, Combating the Prescription Painkiller Epidemic: A National Prescription Drug Reporting Program, 40 Amer. J.L. & Med. 85, 96 (2014)CrossRefGoogle ScholarPubMed (quoting Felix Gillette, American Pain: The Largest U.S. Pill Mill's Rise and Fall, Bloomberg Businessweek (June 6, 2012), http://www.bloomberg.com/bw/articles/2012-06-06/american-pain-the-largest-u-dot-s-dot-pill-mills-rise-and-fall []) (interviewing a former pill mill operator) (internal quotation marks omitted).

303 See, e.g., Rigg, Khary K. et al., Prescription Drug Abuse & Diversion: The Role of the Pain Clinic, 40 J. Drug Issues, 681, 686-87 (2010)CrossRefGoogle ScholarPubMed (quoting a “pill mill” participant as saying that “[the physicians] are there for the money”).

304 See generally id. (interviewing prescription drug abuses in South Florida to better understand pain clinics).

305 Id. at 687-90 (internal quotation marks omitted).

306 See Brown, Richard P. et al., Adrenocortical Function and Suicidal Behavior in Depressive Disorders, 17 Psychiatry Res. 317, 317 (1986)CrossRefGoogle ScholarPubMed (listing David Brizer, M.D., as a “Research Assistant Professor of Psychiatry, New York University Medical Center at Manhattan Psychiatric Center.”).

307 See Dr. Feel Good Fesses Up, Rockland County Times (Mar. 1, 2013), http://www.rocklandtimes.com/2013/03/01/dr-feel-good-fesses-up/ [http://perma.cc/3FFS-BKWG].

308 Searching for David Brizer on the New York Professional Misconduct & Professional Discipline web site shows that he voluntarily surrendered his license on July 29, 2013. Physician Information, N.Y. State Dep't of Health, Office of Prof'l Med. Conduct, http://w3.health.state.ny.us/opmc/factions.nsf/58220a7f9eeaafab85256b180058c032/e569462f71b4cbe785257a700050f866?OpenDocument [http://perma.cc/58LT-AALB]. The surrender supersedes the Interim Order in the matter. See In the Matter of David Allen Brizer, M.D., Interim Order, N.Y. State Dep't of Health (Sept. 4, 2012), http://w3.health.state.ny.us/opmc/factions.nsf/58220a7f9eeaafab85256b180058c032/e569462f71b4cbe785257a700050f866/$FILE/BRD%20144516.pdf [http://perma.cc/9KEA-4VZJ] [hereinafter Brizer Order]

309 See, e.g., Brizer, David A., Religiosity and Drug Abuse Among Psychiatric Inpatients, 19 Amer. J. Drug & Alcohol Abuse 337, 337 (1993)CrossRefGoogle ScholarPubMed (discussing “treatment outcomes of chemically dependent patients”); Brizer, David A. et al., Treatment Retention of Patients Referred by Public Assistance to an Alcoholism Clinic, 16 Amer. J. Drug & Alcohol Abuse 259 (1990)CrossRefGoogle Scholar (discussing treatment for alcoholics); Brizer, David A. et al., A Rating Scale for Reporting Violence on Psychiatric Wards, 38 Hosp. & Community Psychiatry 769 (1987)Google ScholarPubMed (discussing the incidence of violence in psychiatric institutions); Brown et al., supra note 306 (discussing the effect of adrenocortical function on psychiatric condition).

310 Brizer, David, Book Review, 49 Psychiatric Servs. 1104 (1998)CrossRefGoogle Scholar (reviewing Joel Paris, Social Factors in the Personality Disorders: A Biopsychosocial Approach to Etiology and Treatment (1996)) (original pagination unavailable), http://ps.psychiatryonline.org/doi/full/10.1176/ps.49.8.1104 [http://perma.cc/FEK3-Y8WC].

311 By 2003, he is listed as chair of psychiatry at Norwalk Hospital in Norwalk, Connecticut. Brizer, David, Book Review, 54 Psychiatric Servs. 1174, 1174 (2003)CrossRefGoogle Scholar (reviewing Daniel Wegner, The Illusion of Conscious Will (2002)).

312 See, e.g., Brizer, David, Book Review, 28 J. Addictive Diseases 280, 280 (2009)CrossRefGoogle Scholar (reviewing Susan Cheever, Desire: Where Sex Meets Addiction (2008)) (listing only a city in New York under author affiliations).

313 See U.S. v. MacKay, 715 F.3d 807, 813 (10th Cir. 2013); Press Release, Federal Bureau of Investigation, Salt Lake City Division, Brigham City Doctor Indicted on Drug distribution Charges (Aug. 5, 2010), https://www.fbi.gov/saltlakecity/press-releases/2010/slc080510.htm [http://perma.cc/DE72-74TU].

314 The book is Clinical Addiction Psychiatry (David Brizer & Ricardo Castaneda eds., 2010).

315 Steve Lieberman, Former Nyack Psychiatrist Gets Probation for Selling Oxy Scripts, Lohud (Feb. 7, 2014), http://www.lohud.com/story/news/local/westchester/2014/02/07/former-nyack-psychiatrist-gets-probation-for-selling-oxy-scripts-/5283221/ [http://perma.cc/HD4L-SGAF].

316 See Stephen Rex Brown, Midtown Doc David Brizer was like a one-man Pfizer, selling prescriptions for Oxycodone and other pills, authorities said, Pfizer, N.Y. Daily News (Feb. 11, 2013, 3:40 PM), http://www.nydailynews.com/new-york/doc-drug-dealer-article-1.1261132.

317 See David Brizer, Psychology Today, https://therapists.psychologytoday.com/rms/prof_detail.php?profid=132469&sid=1428614767.156_7324&county=Queens&state=NY&spec=13&tr=ResultsName [http://perma.cc/4HEE-MPKY].

318 See David Brizer: Responsible Reliable Housesitter, Single Male, Physician & Writer, CareGuide, http://housesitter.com/responsible-reliable-housesitter-single-male-physician-writer-house-sitter-new-york-ny [http://perma.cc/WAR6-HJW8]; David Brizer: Writer, MeetAWriter, http://meetawriter.com/david-brizer-writer-new-york-ny [http://perma.cc/YP2D-KDYX] (The pictures of Mr. Brizer and his self-description match the stories on his indictment) (screenshots on file with author).

319 Brizer Order, supra note 308.

320 See Volkman v. U.S. Drug Enforcement Admin., 567 F.3d 215, 225 (6th Cir. 2009) (“[Dr. Volkman] was, at times, the largest practitioner-purchaser of oxycodone in the nation, and the DEA's 2005 audit revealed that Volkman could not account for thousands of dosage units.”).

321 In the Matter of Paul H. Volkman, M.D., Report and Recommendation, Oh. St. Med. Bd. (Dec. 10, 2008), http://med.ohio.gov/formala/35070722.pdf [http://perma.cc/2PA8-Z42N].

322 See U.S. v. Volkman, 736 F.3d 1013, 1017 (6th Cir. 2013).

323 See Brief and Appendix of Defendant-Appellee at 12, 14, Frey v. City of Chicago, 288 Ill. App. 3d. 1094 (Ill. App. Ct. 1st Dist., 5th Div. 1994) (Nos. 94-1102, 94-1544), 1994 WL 16168801 (The nurse at CMH “asked him if he was sure about the intubation. Based on her own experience with epiglottitis, she told him that it would be a difficult intubation [and] … advised that he immediately transfer Amanda to the nearest emergency room. Volkman told her not worry about it — he had had two years of experience in anesthesia — and he hung up the telephone.”) (emphasis added).

324 Id. at 14-23.

325 Id. at 12, 24.

326 See Volkman, 736 F.3d at 1017; Paul H Volkman, M.D., Report and Recommendation, Order to Show Cause and Immediate Suspension of Registration, at ¶ 3 (Feb. 10, 2006), http://med.ohio.gov/formala/35070722.pdf [http://perma.cc/2PA8-Z42N] [hereinafter Volkman Show Cause Order].

327 See Volkman, 736 F.3d at 1017-18.

328 Id. at 1018; see also Volkman Show Cause Order, supra note 326, at ¶ 9 (Feb. 10, 2006), http://med.ohio.gov/formala/35070722.pdf [http://perma.cc/2PA8-Z42N].

329 Volkman, 567 F.3d at 217-18, 225.

330 Id. at 218.

331 See id.

332 Paul H. Volkman, Order to Show Cause and Immediate Suspension of Registration, at ¶ 15 (Feb. 10, 2006), http://med.ohio.gov/formala/35070722.pdf [http://perma.cc/2PA8-Z42N] [hereinafter Volkman Immediate Suspension]. To put that in context, the maximum dose per day of either drug or in combination should be 8 to 12 pills per day because of the liver damage associated with acetaminophen. See FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure, FDA, http://www.fda.gov/Drugs/DrugSafety/ucm239821.htm [http://perma.cc/A7DW-8282]. There is absolutely no justification for these prescriptions as they exceed even maximum doses significantly, even if they were for a 90-day supply.

333 Volkman Immediate Suspension, supra note 332, at ¶ 19.

334 United States v. Volkman, 736 F.3d 1013, 1018 (6th Cir. 2013).

335 United States v. Volkman, 797 F.3d 377, 384 (6th Cir. 2015).

336 Volkman v. U.S. Drug Enforcement Agency, 567 F.3d 215, 219 (6th Cir. 2009) (denying Volkman's appeal of the DEA's actions).

337 See Memorandum in Support of Jurisdiction at Appx. 6, 4, Eastley v. Volkman, 972 N.E.2d 512 (Ohio 2012) (No. 11-0605); Eastley v. Volkman, 972 N.E.2d 517, 521(Ohio 2012).

338 Paul Volkman, Why DEA Goes After Pain Docs, War on Docs/Pain Crisis Blog (Apr. 1, 2007), http://doctordeluca.com/wordpress/archive/volkman-dea-targets-pain-docs/ [http://perma.cc/2QKR-M4SN].

339 Id. (emphasis added).

340 Andrew Colegrove, Many Speak Out as Pill Mill Doctor Sentenced to Four Life Terms, Associated Press (Feb. 14, 2012) http://www.wsaz.com/news/headlines/Federal_Trial_Underway_For_Ohio_Pain_Cinic_Operator__Charged_in_12_Deaths.html [http://perma.cc/AZ3D-U774].

341 See Volkman v. Ohio St. Med. Bd., Decision and Final Judgment Entry Affirming the State Medical Board of Ohio's Permanent Revocation of Appellants Certificate to Practice Medicine and Surgery, (Court of Common Pleas, Franking County, Ohio 2011) (on remand from the Court of Appeals of Ohio Tenth Appellat District (Jan. 2010) (granting motion for remand of decision in Volkman v. State Medical Board of Ohio, Case No. 08 CVF 18288, Decision and Final Entry Dismissing Administrative Appeal, Court of Common Pleas, Franklin County, Ohio (2009)).

342 Press Release, Fed. Bureau of Investigation Cincinnati Division, Chicago Physician Receives Four Life Sentences for Illegally Distributing Pills that Led to Deaths of Four People (Feb. 14, 2012), https://www.fbi.gov/cincinnati/press-releases/2012/chicago-physician-receives-four-life-sentences-for-illegally-distributing-pills-that-led-to-deaths-of-four-people [http://perma.cc/6JLX-PKHN] [hereinafter DEA Press Release].

343 Colegrove, supra note 340.

344 United States v. Volkman, 736 F.3d 1013 (6th Cir. 2013) (affirming the decision in that sentencing was warranted; evidence was sufficient to support convictions for firearm possession in furthering drug trafficking, unlawful distribution, and conspiracy; expert testimony was proper; and defendant's conduct was sufficient to support findings that he acted outside the scope of medical practice and not in usual course of business).

345 Volkman v. United States, 135 S. Ct. 13, 13 (2014) (Alito, J., concurring) (granting cert and remanding but carefully stating that there is no basis for acquittal and remand is limited only to the issue of causation using the standard announced in Burrage); see Appellant's Supplemental Brief, 797 F.3d 377 (No. 12-3212) (filed after the Supreme Court remanded Volkman v. United States in light of Burrage).

346 United States v. MacKay, 715 F.3d 807, 813 (10th Cir. 2013).

347 See generally id. (It is notable that here, like in many of the other cases of misprescribing, the physician failed to attend to basic procedural requirements of care such as taking histories, documenting responses, etc.).

348 Id. at 817-19.

349 Id.

350 Id. at 813.

351 Id. at 823-24 (quoting United States v. Feingold, 454 F.3d 1001, 1004 (9th Cir. 2006)) (internal quotation marks omitted).

352 United States v. MacKay, 20 F. Supp. 3d 1287, 1291 (D. Utah 2014).

353 Id. at 1299 (defendant's sentence reduced in light of Burrage).

354 Id. at 1297.

355 Id. (“To the extent the government attempts to depict MacKay as a despicable type of criminal, the Court disagrees. He has no prior criminal history of any kind and his good works are many and cannot be overlooked.”).

356 See DuBois et al., supra note 51, at 2.

357 Id.

358 See Heath, Joseph, Business Ethics and Moral Motivation: A Criminological Perspective, 83 J. Bus. Ethics 595, 599 (2008)CrossRefGoogle Scholar (“There is no doubt that the majority of white collar crime is motivated by what might broadly be referred to a pecuniary incentives”); see also DuBois et al., supra note 51, at 12.

359 Brezina, Timothy & Topalli, Volkam, Criminal Self-Efficacy: Exploring the Correlates and Consequences of a “Successful Criminal” Identity, 39 Crim. Just. & Behav. 1042, 1042 (2012)CrossRefGoogle Scholar.

360 Id. at 1046-58.

361 Banja, John, The Normalization of Deviance in Healthcare Delivery, 53 Bus. Horizons 139, 143 (2010).CrossRefGoogle ScholarPubMed

362 Heath, supra note 358, at 602-10 (They often acknowledge that their acts are technically criminal but serve a higher purpose and may use one of several neutralizing techniques identified by Sykes & Matza and expanded upon by Heath: 1) “[d]enial of responsibility” (forced to break overly restrictive laws) 2) “[d]enial of injury” (claims of helping rather than harming patients); 3) “[d]enial of the victim” (sometimes in the form of “taking what [is] … owed”); 4) “[c]ondemnation of the condemners” (lashing out at law enforcement); 5) “[a]ppeal to higher loyalties” (did it for the benefit of family or for the benefit of the patients in pain); 6) “[e]veryone else is doing it”; and 7) claim to “[e]ntitlement” (denial of the legitimacy of the broken laws).).

363 Heumann et al., supra note 137, at 174.

364 Id.

365 Fed'n of St. Med. Bds., Report of the Ad Hoc Committee on Physician Impairment 2 (Apr. 1995), http://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/1995_grpol_Physician_Impairment.pdf [http://perma.cc/7PKH-SD87]; see also AMA Council of Mental Health, The Sick Physician: Impairment by Psychiatric Disorders, Including Alcoholism and Drug Dependence, 223 J. Am. Med. A'ssn 684, 686 (1973)CrossRefGoogle Scholar (including “deterioration through the aging process, or the loss of motor skill[s]” as impairment).

366 See Holtman, Matthew C., Disciplinary Careers of Drug-Impaired Physicians, 64 Soc. Sci. & Med. 543, 543 (2007)CrossRefGoogle ScholarPubMed.

367 Id. at 545.

368 Id. at 551.

369 See McLellan et al., supra note 25, at 2.

370 Merlo, Lisa J. & Gold, Mark S., Prescription Opioid Abuse and Dependence Among Physicians: Hypotheses and Treatment, 16 Harv. Rev. Psychiatry 181, 181 (2008)CrossRefGoogle ScholarPubMed.

371 Id. at 183.

372 Id.

373 Id.

374 Id. at 184.

375 Id.

376 Morrow, Carol Klaperman, Sick Doctors: The Social Construction of Professional Deviance, 30 Soc. Probs. 92, 104 (1982)CrossRefGoogle ScholarPubMed.

377 Id. at 93.

378 See id.

379 Brian Goldman, Helping the Impaired Physician: A Program for Colleagues 8 (1998), http://www.fanlight.com/downloads/Helping%20the%20Impaired%20Physician.pdf [http://perma.cc/Y6V6-YDRD].

380 Cummings, Simone Marie et al., Mechanisms of Prescription Drug Diversion Among Impaired Physicians, 30 J. Addictive Diseases (2011)CrossRefGoogle ScholarPubMed (original pagination unavailable).

381 Parran, Theodore V. Jr. & Grey, Scott F., The Role of Disabled Physicians in the Diversion of Controlled Drugs, 19 J. Addictive Diseases 35, 39-40 (2000)CrossRefGoogle ScholarPubMed.

382 McLellan, A. Thomas et al., Five Year Outcomes in a Cohort Study of Physicians Treated for Substance Use Disorders in the United States, 337 Brit. Med. J. 1154, 1155 (2008)CrossRefGoogle Scholar.

383 Merlo & Gold, supra note 370, at 185 (many states allow physicians to enter treatment anonymously and avoid being reported to the board of medicine if they do so voluntarily).

384 Id. at 185.

385 Id. at 190.